JP2018509225A - Heart valve prosthesis delivery system and method for delivering a heart valve prosthesis with an introducer sheath - Google Patents

Abstract

The present disclosure relates to a delivery system, a catheter system, and a method for minimally invasive application of a prosthesis to an individual in need thereof, and a method for loading a catheter system and / or delivery system into a prosthesis.

Description

  The present disclosure relates to a delivery system, a catheter system, and a method for minimally invasive application of a prosthesis to an individual in need thereof, and a method for loading a catheter system and / or delivery system into a prosthesis.

  This application includes EP 131733217.4 and EP 131822346.0, U.S. Pat. No. 8,790,395, and U.S. Patent Application Publication 2014/0081388 (3/20). / 14), the related disclosure of which is hereby incorporated by reference as if it were expressly described, all of which are assigned to the assignee. Is incorporated into.

  This disclosure relates to the field of medical devices, and in particular, to prostheses that are adapted to be implanted into an individual in need thereof to restore proper body function by minimally invasive methods and means applicable thereto.

  Examples of prostheses that are deployed by minimally invasive methods are stents and heart valves such as aortic and mitral heart valves. Heart valves are today applied by, for example, transapical, transfemoral, or transclavian routes. The transapical path is very straight through the break between the patient's tears and the top of the heart, and therefore only requires a short distance to the delivery site. The transfemoral arterial route is a very convenient method and widely used because it only requires a cut in the patient's leg to gain access to the vasculature.

  Typically, the prosthesis is applied by a delivery system, also called a catheter. The requirements for transfemoral delivery catheters are complex compared to transapical routes. This is because, for example, in the delivery of aortic heart valves, relatively long distances and bends must be manipulated, which entails certain difficulties.

  One example of such a delivery system is disclosed in EP 2387777. This patent describes a transfemoral artery catheter for delivery of an aortic heart valve. This patent does not disclose or suggest the embodiments disclosed herein.

  Typically, the prosthesis must be loaded onto the catheter and crimped to a small size in a releasable manner for delivery through the patient's vasculature and delivery to the implantation site. Different systems known in the prior art use different sizes such as 22, 20 or 18 French. Therefore, the prosthesis must be squeezed together, which suggests a risk of damaging the valve pericardial material.

  Also, accurate positioning is another problem, perhaps the ability of the catheter system to reposition the prosthesis in the process of delivering and applying the prosthesis to the target site and location within the patient. Termination of the procedure after partial release of the prosthesis and complete recovery of the prosthesis is another advantage that cannot be envisioned by many prior art catheter systems.

  Another problem is the diameter size of the catheter system. The diameter size of the crimped prosthesis within the catheter for delivery through the patient's vasculature is important. Many known systems do not achieve the proper crimping size, and in many cases the known systems adversely affect the tissue during the crimping procedure.

  Furthermore, the crimping of the prosthesis itself represents a challenge. In particular, crimping in a manner that does not damage, stretch and / or tighten the prosthetic tissue is often not adequately achieved with known systems. Even if the immediate damage due to crimping cannot be evident, the crimping often still adversely affects the tissue, in which case the valve in the heart valve and even the tissue corresponding to the stent component, such as the heart It has an adverse effect on the durability of the membrane structure.

  Yet another problem in delivery is the manipulation of the prosthesis by the catheter through the vasculature and its bends. The fact that the vasculature is narrow and must pass through a significant bend with a narrow angle, especially at the aortic entrance into the heart, represents a considerable challenge for such delivery procedures and devices.

  Various implications regarding the present disclosure are also included below.

  Since the advent of endovascular techniques and techniques, minimally invasive surgical procedures have developed considerably. Embodiments of the present disclosure relate to a system for delivering an endoprosthesis into an implantation site within a patient's heart. For example, embodiments of the present disclosure relate to a system for delivering and positioning a transcatheter heart valve used in the treatment of heart valve stenosis (narrow portions) and / or heart valve dysfunction.

  Embodiments of the present disclosure also relate to a dedicated delivery system for an endoprosthesis that includes a foldable and expandable prosthesis that incorporates a stent that is delivered to an implantation site using, for example, a dedicated catheter and preformed sheath. .

  The expression “a narrow portion of a heart valve (stenosis) and / or heart valve dysfunction” is intended to include one or more heart valve functional defects that are genetic or have progressed. Although this type of heart defect may affect each of the four heart valves, the valves in the left ventricle (aortic valve and mitral valve) are often the right part of the heart (pulmonary valve and valvular valve). It is much more affected than the tricuspid valve. A functional defect can result in a narrow portion (stenosis), an inability to close (dysfunction), or a combination of the two (composite defects). This disclosure can be implanted transluminally in a patient's body to treat heart valve defects, among other indications, and can be expanded radially after being introduced percutaneously. The present invention relates to a delivery system that utilizes an endoprosthesis that includes an expandable stent.

  In current treatments for severe stenosis of heart valves and / or heart valve dysfunction, stenotic or diseased heart valves are replaced by endoprostheses. Biological or mechanical valve models are usually surgically sewn into the heart valve base through the chest opening after removal of the diseased heart valve, but have generally been used for this purpose. Such treatment or surgery requires the use of cardiopulmonary lungs to maintain the patient's blood circulation during the procedure, and cardiac arrest is induced during implantation of the prosthesis. This is a dangerous surgical procedure for the patient, with associated risks as well as a long post-operative treatment and recovery phase. Such surgery is often not considered to be a legitimate risk in the case of multi-disease patients.

  Recently, minimally invasive forms of therapy have been developed that are characterized by allowing treatment to be performed under local anesthesia. One approach uses a catheter system for implanting a self-expanding stent to which a foldable valve prosthesis is connected. Such a self-expanding endoprosthesis can be guided by a catheter system through an inguinal artery or vein to an implantation site in the heart. After reaching the implantation site, the stent can be subsequently deployed.

  However, there is a risk of incomplete or inaccurate implantation of the endoprosthesis using the solution described above. In other words, the endoprosthesis to be implanted must be accurately positioned and aligned in the longitudinal direction. This is especially true prior to the advent of the system, using advanced skills on the part of the operating surgeon or cardiologist-even if so-that the stent is sufficiently accurate both laterally and longitudinally. This is only possible if the associated endoprosthesis is located in the exact region of the affected heart valve of the patient to be treated.

  Based on the issues outlined above, certain embodiments of the present disclosure address the problem of delivering and positioning a dedicated endoprosthesis for treating a stenotic heart valve or heart valve dysfunction, This realizes optimum positioning accuracy and fixing of the installed device. In addition, treatment of a stenotic heart valve or heart valve dysfunction should allow for routine treatment of a stenotic heart valve or heart valve dysfunction with a simple procedure without placing significant stress on the patient.

  One object of certain embodiments of the present disclosure was to provide a catheter system that is easy to handle for delivering a prosthesis, such as a heart valve. In particular, this system allows the heart valve to be safely loaded and crimped without the side effects caused by loading and crimping procedures.

  Another object of certain embodiments of the present disclosure is to provide a catheter and delivery system for a prosthesis that is designed to facilitate delivery of the prosthesis to a target site. In particular, a system configuration is provided that can be operated through the vasculature of a patient without the disadvantages known in the prior art.

  Another object of certain embodiments of the present disclosure is a form in which the prosthesis can be safely positioned and delivered to the target site, with the possibility of ending the delivery procedure and storing the prosthesis until a particular treatment time point. Is to provide. Furthermore, it is an object of certain embodiments of the present disclosure to allow free movement of the prosthesis in the axial and rotational directions.

  Another object of certain embodiments of the present disclosure is to provide a gradual release of the prosthesis to accurately place the prosthesis at the target site to allow fine adjustment of the repositioning and / or positioning procedure in this manner. Is to bring

  Embodiments of the present disclosure, in one aspect, include i. Steering means; ii. The present invention relates to a catheter system comprising a heart valve, optionally delivery means for a balloon-expandable or self-expandable heart valve, the steering means and the delivery means being movable coaxially and independently in the direction of rotation.

  In another aspect, an embodiment of the present disclosure is a delivery system for a heart valve comprising: i. Steering means; ii. Delivery means for a heart valve; iii. The present invention relates to a delivery system including an introducer sheath and capable of moving the steering means, the delivery means, and the introducer sheath coaxially and independently in the circumferential direction.

  In yet another aspect, an embodiment of the present disclosure is a method for delivering a heart valve to a patient's heart comprising the steps of: i. In a first step, an introducer comprising an introducer sheath is placed into the patient's vasculature; ii. In a second step, a catheter system comprising a self-expanding heart valve fixed is introduced through the introducer into the patient's vasculature, iii. In a third step, positioning the self-expanding heart valve proximal to the target site in the patient's heart, optionally positioning the heart valve approximately in the center of the target site; iv. In a fourth step, positioning the self-expanding heart valve at the target site; In a fifth step, the self-expanding heart valve is partially released from the catheter system, vi. The sixth step relates to a method of completely releasing the self-expanding heart valve from the catheter system.

In yet another aspect, an embodiment of the present disclosure is a method of loading a self-expanding heart valve on a delivery means of a catheter system having an inner shaft, an attachable distal tip, and at least one outer sheath. There,
Compressing the self-expanding heart valve radially and placing the compressed self-expanding heart valve into the tubular retainer, the retainer preventing the self-expanding valve from expanding radially , Steps and
Passing the inner shaft of the delivery system through the central opening of the compressed self-expanding heart valve;
Attaching a distal tip to the shaft of the delivery system;
Forcing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
Removing a tubular retainer from the compressed self-expanding heart valve;
A method comprising:

  In yet another aspect, embodiments of the present disclosure relate to a two-stage deployment procedure for a heart valve.

  In yet another aspect, embodiments of the present disclosure are particularly directed to attachment of a heart valve in a catheter or in a delivery system, where only the sides of the heart valve are secured and / or covered by catheter securing means. However, essentially the central part of the heart valve is not covered.

  In yet another aspect, embodiments of the present disclosure relate to a steerable catheter for delivery of a heart valve.

  Briefly, the transcatheter heart valve is a novel preformed sheath and / or steering to allow installation utilizing the advantages of the exclusive JenaValve® brand prosthesis. Delivered by a transapical (TA) and / or transfemoral artery (TF) delivery system featuring a possible catheter.

  According to some embodiments, the transcatheter heart valve delivery system includes a pericardial THV system with a dedicated prosthesis, a prosthesis delivery system, and a separate valve loader.

  According to some embodiments, the prosthesis is constructed from porcine pericardial tissue and has special struts as described further below, illustrated, and claimed. And a polyester suture attached to a self-expanding Nitinol stent scaffold that can be fitted into a transapical or transfemoral artery catheter delivery device.

  According to some embodiments, a transapical and / or transfemoral artery delivery system is a crown-shaped configuration, as further described, illustrated, and claimed below. And foldably accommodate and deliver a scaffold that works with a preformed sheath and / or a steerable catheter.

  According to some embodiments, the system is compatible with at least three valve sizes that accept a natural annulus diameter of at least about 21-27 mm.

  According to one aspect, the present disclosure provides a catheter system for introducing an expandable heart valve into a patient's body, the catheter system comprising delivery means for the heart valve.

  In some aspects of the present disclosure, the delivery means comprises a catheter tip and a catheter shaft. The catheter tip of the delivery means has a seat for receiving the heart valve to be introduced into the patient's body in its folded or crimped state. The catheter tip further comprises a securing means for releasably securing the heart valve to the catheter tip.

  The seat portion of the catheter tip is constituted by first holding means and second holding means. In some embodiments of the present disclosure, the first holding means and the second holding means may be constituted by a first sleeve-shaped member and a second sleeve-shaped member.

  The first holding means of the catheter tip serves to reversibly fix the distal end portion of the heart valve to the delivery means, in particular to the catheter tip of the delivery means. On the other hand, the second holding means of the catheter tip serves to reversibly fix the proximal end portion of the heart valve to the delivery means, in particular to the catheter tip of the delivery means.

  The first and second holding means can move relative to each other and can also move relative to the catheter tip securing means.

  According to some embodiments of the present disclosure, the catheter shaft of the delivery means comprises a first force transmission means and a second force transmission means.

  The distal end portion of the first force transmitting means is connected to or connectable to the first holding means of the catheter tip, and the proximal end portion of the first force transmitting means is the handle of the delivery means. Connected to or connectable to the first operating means. The distal end portion of the second force transmitting means is connected or connectable to the second holding means of the catheter tip, and the proximal end portion of the second force transmitting means is the handle of the delivery means. Connected to or connectable to the second operating means.

  According to some embodiments of the present disclosure, the handle of the delivery means has at least one first operating means and at least one second operating means, using these operating means to the catheter tip. The catheter tip of the delivery means can be appropriately manipulated so that the fixed expandable heart valve can be released from the catheter tip in stages or in a predetermined or definable sequence of events.

  According to a preferred embodiment of the present disclosure, the catheter tip has first and second holding means that may be manipulated using the handle of the delivery means, for example in the form of a sleeve-shaped member. These retaining means are used to releasably and reversibly fix the distal and proximal end portions of the heart valve to the catheter tip.

  In some embodiments of the present disclosure, the first retention means releasably and reversibly secures a first functional component of the heart valve, such as a stent retention hoop or alternatively a stent positioning hoop. While the second retaining means serves to releasably and reversibly fix the second functional component of the heart valve, eg, the positioning hoop of the stent, or alternatively, retain the stent Help accept the hoop.

  With regard to the handle of the delivery means, on the one hand, the first operating means is a catheter tip so that a predeterminable longitudinal movement of the first holding means can be brought with respect to the fixing means when the first operating means is activated. Preferably it is provided to cooperate with the first holding means. On the other hand, the second operating means cooperates with the second holding means of the catheter tip so that a pre-determinable longitudinal movement of the second holding means can be provided with respect to the fixing means.

  According to some embodiments of the present disclosure, the first and second retaining means serve only to secure the distal and proximal end portions of the heart valve to the catheter tip. Where the first and second retaining means are configured as first and second sleeve-shaped members, these sleeve-shaped members are used to secure the distal and proximal end portions of the heart valve to the catheter tip. The first and second sleeve-shaped members have such a length that there is a gap between them.

  According to some embodiments of the present disclosure, the first force transmission means of the delivery means is constituted by a first catheter tube defining a first lumen, and the second force transmission means of the delivery means. Is constituted by a second catheter tube defining a second lumen. The second catheter tube has a cross section that is smaller than the cross section of the first catheter tube. The first catheter tube is disposed concentrically and coaxially with the second catheter tube, and the second catheter tube is received within a first lumen defined by the first catheter tube.

  However, unlike the first and second sleeve-shaped members of the catheter tip, the catheter tip securing means cannot move relative to the handle of the delivery means. Rather, the securing means is connected to the handle of the delivery means by using a securing tube having a distal end connected to the securing means and a proximal end connected to the body of the handle of the delivery means. The fixed tube has a cross section that is smaller than the cross section of the first catheter tube. In particular, the first catheter tube is arranged concentrically and coaxially with both the second catheter tube on the one hand and the stationary tube on the other hand.

  Preferably, the fixation tube is first such that the fixation tube is received in a first lumen defined by the first catheter tube and the second catheter tube is received in a passage defined by the fixation tube. Having a cross section smaller than that of the second catheter tube and larger than that of the second catheter tube. The passage defined by the fixation tube has a diameter sufficient to receive the second catheter tube so that the second catheter tube can move relative to the fixation tube.

  The second lumen defined by the second catheter tube has a diameter sufficient to receive the guide wire. The second catheter tube is made from a rigid material including, for example, nitinol, stainless steel, or a rigid plastic material. The material of the distal end portion of the second catheter tube is more flexible than the material of the proximal end portion to allow the distal end portion of the catheter shaft to pass through the aortic arch during insertion of the catheter tip. You may have.

  In some embodiments of the present disclosure, the distal end portion of the second catheter tube terminates with a flexible catheter end tip having an atraumatic shape. The flexible catheter end tip includes a second lumen and position defined by the second catheter tube so that a guidewire received within the second lumen of the second catheter tube can pass through the channel of the flexible catheter end tip. Matched channels are provided. The second sleeve-shaped member of the catheter tip is a flexible catheter such that the open end of the second sleeve-shaped member is oriented in the proximal direction opposite the flexible catheter end tip and the second catheter tube. Connected to end chip.

  The fixation tube is preferably formed from a hard material, such as a hard plastic material, stainless steel, or Nitinol. The distal end of the fixation tube terminates with a fixation means, which is also formed from a hard material, such as a hard plastic material or stainless steel. The passage defined by the fixation tube is aligned with the channel passing through the fixation means. In this way, the second catheter tube is received in the passage of the fixation tube and in the channel of the fixation means so that it can move relative to the fixation tube and the fixation means.

  A securing tube is provided for connecting the securing means to the handle of the delivery means. For this purpose, the fixation tube has a distal end connected to the fixation means and a proximal end connected to the body of the handle of the delivery means.

  The first catheter tube can be bent but is preferably formed from an inelastic material. For example, the first catheter tube may be formed at least in part from a knitted or non-knitted catheter tube. As such, the first catheter tube may have a highly rigid knitted reinforcement similar to the catheter body described in US Pat. No. 4,665,604, incorporated herein by reference. Good.

  The first catheter tube is adapted to transmit compressive and tensile forces from the first operating means of the handle of the delivery means to the first holding means of the catheter tip without unduly changing its overall length. It shall be. The distal end of the first catheter tube terminates in an overhanging portion as a transition to the portion defining the first retaining means of the catheter tip.

  The overhanging portion and the first retaining means may be integrally formed and may be connected to the distal end portion of the first catheter tube.

  Alternatively, the first retaining means and the overhanging portion of the first catheter tube are all made of the same material so that the overhanging portion and the first holding means are the same element, and the same raw tube before the expansion process May be produced from

  According to another aspect of the present disclosure, the catheter system further comprises steering means. The steering means serves to guide the delivery means, in particular the catheter tip of the delivery means, as it is advanced through the patient's vasculature.

  In some embodiments of the present disclosure, the steering means comprises a steerable catheter tube having a proximal end portion and a distal end portion. The proximal end portion of the steerable catheter tube is connected to or connectable to the handle of the steering means.

  The steering means handle is provided with operating means, for example in the form of a rotatable knob or wheel, which can be used to control the bending link area of the steerable catheter tube.

  According to other embodiments disclosed herein, the steerable catheter tube of the steering means is provided without any bending link region and can be operated by corresponding operating means. Rather, in these embodiments, the material of the distal end portion of the steerable catheter tube may be more flexible than the material of the proximal end portion. In this way, the distal end portion of the steerable catheter tube can easily pass through, for example, the aortic arch during insertion of the steerable catheter tube.

  In some embodiments disclosed herein, the steering means handle is provided with an operating means capable of controlling the bendable link region of the steerable catheter tube, wherein the operating means is It is preferable to have a detent device to allow the set deflection of the bendable link region of the possible catheter tube to be fixed. For example, the operating means can be provided with a suitable catch mechanism that cooperates with the body of the steering means handle. In particular, the bending link area of the steerable catheter tube can be connected to the operating means of the steering means by means of a control wire, so that when the operating means is activated, the bending link area is pre-defined via the control wire. A pulling force is exerted on the bendable link region of the steerable catheter tube that provides a pre-definable deflection.

  However, as a matter of course, when such a steerable catheter tube is provided with such a bendable link region, the steerable catheter tube or the steerable means for manipulating the bendable link region of the steerable catheter tube as an operation means Other embodiments may be selected.

  According to some embodiments disclosed herein, the proximal end portion of the steerable catheter tube of the steering means terminates at the port portion of the steering means or the port of the steering means Connected with the part. The port portion of the steering means serves to introduce the catheter tip and the catheter shaft of the delivery means into the steerable catheter tube. For this purpose, the port portion of the steering means has a lumen defining a passage extending through the port portion, the distal end portion of the passage being positioned with the proximal end portion of the steerable catheter tube. To be combined.

  The port portion of the steering means is preferably incorporated in or connected to the steering means handle.

  The catheter tip and catheter shaft of the delivery means can be introduced into the steering catheter tube (via the port portion of the steering means). The catheter shaft of the delivery means, in particular the first catheter tube of the catheter shaft of the delivery means, is movable relative to the steerable catheter tube. In particular, the steerable catheter tube terminates proximal to the catheter tip, where the cross-section of the proximal end portion of the introducer sheath is the cross-section of the overhang portion provided at the proximal end of the first catheter tube Is substantially the same as or slightly larger than this cross section.

  The proximal end portion of the steering means, in particular the proximal end portion of the port portion of the steering means, can be releasably connected to the handle of the delivery means.

  According to one aspect of the present disclosure, the catheter system further comprises an introducer having an introducer sheath. The introducer sheath has a cross section that is larger than the cross section of the steerable catheter tube of the steering means.

  The introducer sheath serves as a guiding means for introducing the delivery means and / or the steering means, in particular the steerable catheter tube of the steering means into the patient's vasculature. More particularly, an introducer sheath may define a passage through which the catheter tip and catheter shaft of the delivery means and / or the steerable catheter tube of the steering means may be guided to the implantation side in the patient's body. Good.

  The introducer sheath has a distal end, a proximal end, and a passage extending between the distal end and the proximal end. The introducer sheath is such that the distal end of the introducer sheath terminates more proximally than the catheter tip of the delivery system when the catheter shaft and catheter tip of the delivery system are fully introduced into the introducer sheath. Have a length.

  Once at least a portion of the catheter shaft of the delivery means or at least a portion of the steerable catheter tube of the steering means has been introduced into the passage defined by the introducer sheath, the introducer sheath becomes a portion of the catheter shaft of the delivery means. Alternatively, it is arranged concentrically and coaxially with the steerable catheter tube portion of the steering means.

  However, in any case, the catheter shaft of the delivery means and / or the steerable catheter tube of the steering means can be moved relative to the introducer sheath. In particular, the introducer sheath terminates proximal to the catheter tip, in which case the cross-section of the proximal end portion of the introducer sheath is approximately the same as or slightly less than the cross-section of the steerable catheter tube. Let it be big.

  The proximal end portion of the introducer sheath is connected to the introducer port. The introducer port serves to provide access to the introducer sheath of the introducer that is required to deliver the steerable catheter tube of the delivery means or steering means into the introducer sheath.

  The introducer port can be manually secured to the handle of the delivery means when the catheter shaft of the delivery means is introduced into the passage defined by the introducer sheath, or the steerable catheter tube of the steering means is A base member may be provided that is configured to be manually secured to the steering handle when introduced into the passage defined by the introducer sheath.

  According to some embodiments disclosed herein, the introducer port provides fluid, particularly blood leakage, from the introducer when the introducer sheath is introduced into the patient's vasculature. A seal structure is provided to prevent this.

  In some embodiments disclosed herein, the proximal end portion of the introducer sheath terminates in a crimping portion distal to the introducer port seal structure. The crimping portion of the introducer serves to crimp at least the central portion of the heart valve that is secured to the catheter tip of the delivery means during introduction of the catheter tip into the introducer sheath. As previously mentioned, according to the embodiments disclosed herein, preferably only the distal and proximal end portions of the heart valve are catheter tips of the delivery means by the first and second retaining means. In this case, no dedicated holding means are assigned to the central portion of the heart valve between the distal and proximal end portions of the heart valve.

  The diameter of the central portion of the heart valve that is passed through the crimping portion of the introducer and thereby secured to the catheter tip to crimp the central portion of the heart valve during introduction of the catheter tip into the introducer sheath Is further reduced. In some embodiments disclosed herein, the crimping portion may comprise a conical tubular member, the conical tubular member having an inner diameter that decreases in a distal direction of the tubular member.

  The introducer sheath may be made of a thin material that allows the introducer sheath to deform in length upon transmission of compressive and tensile forces. However, the introducer sheath material should be sufficiently rigid to mechanically avoid kinking of the flexible portion of the distal portion of the catheter shaft during insertion of the catheter tip.

  In some embodiments of the present disclosure, the introducer sheath has a preformed configuration, preferably a curved configuration.

  An inlet may be provided at the proximal end portion of the steering means, introducer, and / or delivery means to inject fluid as needed. In addition, a check valve may be provided at the proximal end portion of the introducer sheath to prevent fluid from leaking out of the introducer sheath.

  The introducer sheath may have a length sufficient to protect the inner wall of the blood vessel through which the catheter tip passes. In addition, a separate introduction system (not belonging to the catheter system) may be provided. At this time, the introduction system may serve as an introduction unit for passing the entire catheter system from the catheter tip to the catheter shaft into the patient's body up to the heart.

  In addition, the introducer sheath reduces the compressive force exerted on the first catheter tube inserted through the introducer sheath. This increases the maneuverability of the steerable catheter tube and the catheter shaft of the delivery means throughout the procedure. The result is that the frictional force is reduced. Furthermore, moving the catheter tip after it has been pushed through the patient's vasculature is greatly improved while reducing the risk of patient injury.

  The length of the introducer sheath depends on the length of the catheter shaft of the delivery means and is generally about 20 cm to 100 cm. However, as will be appreciated by those skilled in the art, all dimensions given herein are intended as an example only, and for certain applications, different dimensions of introducer sheath and It may be replaced by a catheter tube.

  As can be appreciated, the introducer sheath allows for insertion into the patient's blood vessels (arteries or veins) used to move the stent transarterially or via a vein to an inadequate heart valve. Size, i.e., having an outer diameter.

  The introducer sheath may be able to traverse a tortuous path in the patient's body without kinking. The introducer sheath may include an inner smooth liner, an outer polymeric jacket, and a coil reinforcement between the inner and outer layers. This introducer sheath can provide advantageous flexibility without kinking or compression. One or more radiopaque bands or markers may be incorporated into the introducer sheath material to allow accurate positioning of the distal end of the introducer sheath for positioning accuracy. As known to those skilled in the art, other known materials may be suitable for a particular purpose.

The catheter system is particularly adapted to deliver and implant a heart valve as described, for example, in European Patent Application No. 07 110 318 or European Patent Application No. 08 151 963. Accordingly, in some embodiments of the present disclosure, a heart valve is used that includes a stent and a heart valve prosthesis attached to the stent. A stent has the following elements:
A first holding region to which a heart valve prosthesis can be attached;
The fixation of the catheter tip of the delivery means to the opposite second holding region with at least one holding element, for example in the form of a holding eye or in the form of a holding head. A second holding region that can be in releasable engagement with the means;
-At least one retention hoop capable of fastening the heart valve prosthesis;
-At least one positioning hoop formed to engage within the pocket of the natural heart valve in the implanted state of the stent and thus to allow automatic positioning of the stent within the patient's aorta Preferably three positioning hoops;
Have

  In particular, in the present description, an expandable heart valve stent is attached to the stent in a particularly simple manner, for example via the aorta of the patient to be treated (transarterially or transfemorally). A catheter system that can be pushed to an implantation site with a heart valve prosthesis attached is disclosed. Preferably, the catheter tip provided in the distal end region of the catheter system that can receive the stent with the heart valve prosthesis can be made sufficiently small relative to the outer diameter of the catheter so that the transarterial or transfemoral artery with the catheter system During typical access, the total free cross section available in the aorta is not completely filled.

  The expandable heart valve stent can be temporarily secured in a crimped state to the catheter tip of the delivery means during implantation with the heart valve prosthesis attached to the stent.

  Accordingly, a catheter system that is configured for transarterial or transfemoral access has a heart valve stent that is transarterially or transfemorally articulated with the heart valve prosthesis attached to the stent. Suitable for insertion into the body, for example, the catheter tip of the delivery means of the catheter system is inserted by puncture of the femoral artery (inguinal artery).

  In particular, if the catheter system is configured for transarterial or transfemoral access, the catheter shaft of the delivery means may be configured such that it has both kink resistance and flexibility, Thereby, a bending radius of at most 4 cm, for example at most 3 cm, can be achieved at least in the distal end region of the catheter shaft.

  Hereinafter, various embodiments will be described with reference to the accompanying drawings.

1 is a side view of one embodiment of a delivery system for transfemoral / transarterial insertion of an expandable heart valve. FIG. It is a side view of one Embodiment of the delivery means of the delivery system which concerns on FIG. 2b is a cross-sectional side view of the delivery means of FIG. 2a. 2b is a side sectional view of the catheter tip of the delivery means of FIG. 2a. It is a sectional side view of one Embodiment of the steering means of the delivery system which concerns on FIG. 3b is a side sectional view of the steering means of FIG. 3a. It is a sectional side view of one Embodiment of the introduction body of the delivery system which concerns on FIG. FIG. 6 is a schematic diagram illustrating a transfemoral / transarterial implantation procedure for a heart valve stent. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 2b is a side sectional view of components of the delivery means of FIG. 2a. 1 is a plan view of an overall system for TF transcatheter heart valve delivery according to the present disclosure. FIG. FIG. 2 is an enlarged view of the system of FIG. 1 according to the present disclosure. FIG. 1 is a schematic view of a JenaValve® brand prosthesis and an actual view of the prosthesis. 2 is a depiction of a TF delivery system. It is another figure of TF transmission system. FIG. 6 is a further view of a preformed sheath according to the present disclosure. 1 is a side view of one embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 1 is a side view of one embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter. FIG. 10 is a side view of another embodiment of an apparatus for facilitating removal of a distal end of a catheter from an introducer sheath or guide catheter.

  Hereinafter, exemplary embodiments of the present disclosure will be described in more detail.

  FIG. 5 schematically illustrates an example of a method that allows transarterial or transfemoral access to a patient's heart. In the example view according to FIG. 5, the delivery system 100 is used to push the heart valve stent 150 through the femoral artery and into the aortic valve. In the following, embodiments of a delivery system 100 suitable for transarterial or transfemoral access will be described.

  For example, as depicted in FIG. 1, a delivery system 100 according to an exemplary embodiment of the present disclosure includes a delivery means 10, a steering means 30, and an introducer 40.

  The delivery means 10 has a catheter tip 11, a catheter shaft 12, and a handle 13 connected to the proximal end portion of the catheter shaft 12. In this regard, reference is also made to FIGS. 2a and 2b.

  For example, as shown in FIG. 2 c, the catheter tip 11 of the delivery means 10 has a seat for receiving a heart valve to be inserted in its crimped state, and a releasably securing heart valve to the catheter tip 11. And fixing means 14.

  The delivery means 10 further comprises a catheter shaft 12 for connecting the catheter tip 11 to the handle 13 of the delivery means 10, the distal end portion of the catheter shaft 12 being the distal end of the catheter tip 11 and the catheter shaft 12. Flexible enough to allow the part to pass through the aortic arch during insertion through the patient's aorta.

  The seat of the catheter tip 11 includes first holding means 15 and second holding means 16, and the first and second holding means 15, 16 may have the same cross section. In the exemplary embodiment shown in FIG. 2c, the first and second holding means 15, 16 are each configured as a sleeve-shaped element. The lengths of these sleeve-shaped elements are each selected such that the seat of the catheter tip is not entirely covered by the sleeve-shaped elements. Rather, as shown in FIG. 2c, the central portion of the catheter tip seat is not always covered.

  The first and second holding means 15, 16 are movable relative to each other and relative to the fixing means 14. For this purpose, a first force transmission means 20 is provided whose distal end portion is connected to the first holding means 15 and whose proximal end portion is connected to the first operating means 17 of the handle 13. In addition, a second force transmission means 21 is provided whose distal end portion is connected to the second holding means 16 and whose proximal end portion is connected to the second operating means 18 of the handle 13. By operating the first and / or second operating means 17, 18 of the handle 13, the first and / or second holding means 15, 16 can be moved relative to each other and relative to the fixing means 14.

  As can be seen from FIGS. 2b and 2c, the first force transmission means 20 may be constituted by a first catheter tube defining a first lumen, and the second force transmission means 21 may be Constituted by a second catheter tube defining two lumens. The second catheter tube may have a cross section that is smaller than the cross section of the first catheter tube. The first catheter tube may be disposed concentrically and coaxially with the second catheter tube, and the second catheter tube is within a first lumen defined by the first catheter tube. Be contained.

  However, unlike the first and second holding means 15, 16 of the catheter tip 11, the fixing means 14 of the catheter tip 11 cannot move relative to the handle 13 of the delivery means 10. Rather, the securing means 14 is connected to the body 19 of the handle 13 by using a securing tube 22 having a distal end connected to the securing means 14 and a proximal end connected to the body 19 of the handle 13. The

  The fixed tube 22 may have a cross section that is smaller than the cross section of the first catheter tube of the first force transmission means 20. In particular, the first catheter tube of the first force transmission means 20 is arranged concentrically and coaxially with both the second catheter tube of the second force transmission means 21 and on the other hand the fixed tube 22. May be.

  In some embodiments, the fixation tube 22 is received within a first lumen defined by the first catheter tube and the second catheter tube is defined within the passage defined by the fixation tube 22. Having a cross section that is smaller than the cross section of the first catheter tube and larger than the cross section of the second catheter tube. The passage defined by the fixation tube 22 has a diameter sufficient to receive the second catheter tube so that the second catheter tube can move relative to the fixation tube 22.

  The second lumen defined by the second catheter tube has a diameter sufficient to receive a guide wire (not shown). The second catheter tube may be made from a rigid material including, for example, nitinol, stainless steel, or a rigid plastic material. The material of the distal end portion of the second catheter tube can be higher than the material of the proximal end portion to allow the distal end portion of the catheter shaft 12 to pass through the aortic arch during insertion of the catheter tip 11. You may have flexibility.

  For example, as can be seen in FIG. 2c, the distal end portion of the second catheter tube terminates with a flexible catheter end tip 23 having an atraumatic shape. The flexible catheter end tip 23 has a second lumen defined by the second catheter tube so that a guidewire received within the second lumen of the second catheter tube can pass through the channel of the flexible catheter end tip. A channel that is aligned with is provided. The second holding means 16 of the catheter tip 11 is such that the open end of the second holding means 16 faces in the proximal direction opposite to the direction of the flexible catheter end tip 23 and the second catheter tube. To the flexible catheter end tip 23.

  According to exemplary embodiments of the present disclosure, the fixation tube 22 is formed from a hard material, such as a hard plastic material, stainless steel, or Nitinol. The distal end of the fixation tube 22 terminates with a fixation means 14, which is also formed from a hard material, such as a hard plastic material or stainless steel. The passage defined by the fixation tube 22 is aligned with the channel passing through the fixation means 14. In this way, the second catheter tube is received in the passage of the fixation tube 22 and in the channel of the fixation means 14 so that it can move relative to the fixation tube 22 and the fixation means 14.

  The first catheter tube of the first force transmission means 20 can be bent but is made of an inelastic material. For example, the first catheter tube may be formed at least in part from a knitted or non-knitted catheter tube. The first catheter tube transmits the compressive force and tensile force from the first operating means 17 of the handle 13 to the first holding means 15 of the catheter tip 11 without changing the entire length of the first catheter tube excessively. It shall be. The distal end of the first catheter tube terminates in an overhanging portion as a transition to the portion of the catheter tip 11 that defines the first retaining means 15.

  The overhanging portion and the first retaining means 15 may be integrally formed and may be connected to the distal end portion of the first catheter tube. In addition, the overhanging portion may constitute the first holding means 15 of the catheter tip 11. The first retaining means 15 and the overhanging portion of the first catheter tube are all made of the same material so that the overhanging portion and the first holding means 15 are the same element, and the same raw tube before the expansion process May be produced from

  For example, referring to FIG. 1, a delivery system 100 according to an exemplary embodiment of the present disclosure is for guiding the delivery means 10, particularly the catheter tip 11 of the delivery means 10 as it is pushed through the patient's vasculature. The steering means 30 is further provided.

  As shown in FIGS. 3a and 3b, the steering means 30 comprises a steerable catheter tube 31 having a proximal end portion and a distal end portion. The proximal end portion of the steerable catheter tube 31 is connected to or connectable to the handle 32 of the steering means 30.

  The handle 32 of the steering means 30 is provided with operating means 33 in the form of, for example, a rotatable knob or wheel, and the bending link region of the steerable catheter tube 31 can be controlled using this operating means 33.

  As shown in FIG. 3 a, the handle 32 of the steering means 30 is also provided with a display means 34 for indicating the degree of bending applied to the bent link region of the catheter tube 31 that can be steered by the operating means 33.

  Although not explicitly shown in FIG. 3a, in some embodiments, the manipulating means 33 has a detent device to allow a set deflection of the bendable link region of the steerable catheter tube 31 to be fixed. It is preferable. For example, an appropriate catch mechanism that cooperates with the main body of the handle 32 of the steering means 30 can be provided in the operating means 33.

  As can be seen from FIG. 3 b, a control wire 35 is provided that connects the bending means of the catheter tube 31 that can steer the operating means 34. During operation of the operating means 33, a tensile force is applied to the bendable link region of the catheter tube 31 that can be steered via the control wire 35, resulting in a predefined or predefinable deflection of the bent link region.

  However, of course, other embodiments may be selected as the operating means 33 of the steering means 30 for deflecting the steerable catheter tube 31 or the bending link region of the steerable catheter tube 31.

  In the exemplary embodiment of the steering means 30 shown in FIG. 3 b, the proximal end portion of the steerable catheter tube 31 of the steering means 30 terminates at the port portion 36 of the steering means 30. The port portion 36 of the steering means 30 serves to introduce the catheter tip 11 and the catheter shaft 12 of the delivery means 10 into the steerable catheter tube 31. For this purpose, the port portion 36 of the steering means 30 has a lumen defining a passage extending therethrough, the distal end portion of the passage being a steerable catheter tube 31. Aligned with the proximal end portion of the.

  As shown in FIG. 1, the catheter tip 11 and catheter shaft 12 of the delivery means 10 can be introduced into the steerable catheter tube 31 (via the port portion 36 of the steering means 30). The catheter shaft 12 of the delivery means 10, in particular the first catheter tube of the catheter shaft of the delivery means 10, can be moved relative to the steerable catheter tube 31. In particular, the steerable catheter tube 31 terminates proximal to the catheter tip 11, where the cross-section of the proximal end portion of the introducer sheath is an overhang provided at the proximal end of the first catheter tube. It shall be approximately the same as or slightly larger than the cross section of the part.

  As shown in FIG. 1, an exemplary embodiment of delivery system 100 is provided with an introducer 40 having an introducer sheath 41. The introducer sheath 41 has a larger cross section than the cross section of the steerable catheter tube 31 of the steering means 30.

  The introducer sheath 41 serves as a guiding means for introducing the delivery means 10 and / or the steering means 30, particularly the steerable catheter tube 31 into the vasculature of the patient. More particularly, the introducer sheath 41 defines a passage through which the catheter tip 11 of the delivery means 10 and the catheter shaft 12 and / or the steerable catheter tube 31 of the steering means 30 are implanted on the patient's body. You may be guided to

  A side cross-sectional view of one embodiment of the introducer 40 is shown in FIG.

  Thus, the introducer sheath 41 has a distal end, a proximal end, and a passage extending between the distal end and the proximal end. The introducer sheath 41 is such that the distal end of the introducer sheath 41 is closer to the catheter tip 11 of the delivery system when the catheter shaft 12 and the catheter tip 11 of the delivery system 100 are fully introduced into the introducer sheath 41. It has a length that terminates at the rear side.

  Once at least a portion of the catheter shaft 12 of the delivery means 10 or at least a portion of the steerable catheter tube 31 of the steering means 30 has been introduced into the passage defined by the introducer sheath 41, the introducer sheath 41 is , Concentrically and coaxially with that portion of the catheter shaft 12 of the delivery means 10 or that portion of the steerable catheter tube 31 of the steering means 30.

  However, in any case, the catheter shaft 12 of the delivery means 10 and / or the steerable catheter tube 31 of the steering means 30 are movable relative to the introducer sheath 41. In particular, the introducer sheath 41 terminates proximally of the catheter tip 11, in which case the cross section of the proximal end portion of the introducer sheath 41 is substantially the same as the cross section of the steerable catheter tube 31 It shall be slightly larger than the cross section.

  The proximal end portion of introducer sheath 41 is connected to introducer port 42. The introducer port 42 provides access to the introducer sheath 41 of the introducer 40 required to deliver the steerable catheter tube 31 of the delivery means 10 or the steering means 30 into the introducer sheath 41. To help.

  The introducer port 42 is introduced into the passage defined by the introducer sheath 41 when the steerable catheter tube 31 of the steering means 30 is introduced into the passage defined by the introducer sheath 41. A base member 43 may be provided that is configured to be manually secured to the steerable catheter tube 31 or configured to be manually secured to the handle 32 of the steering means 30.

  As can be seen from FIG. 4, the introducer port 42 has a seal structure 44 to prevent leakage of fluid, particularly blood, from the introducer 40 when the introducer sheath 41 is introduced into the patient's vasculature. Is provided.

  Also, in the exemplary embodiment of introducer 40 shown in FIG. 4, the proximal end portion of introducer sheath 41 terminates at a crimping portion 45 distal to seal structure 44 of introducer port 42. The crimping portion 45 of the introducer 40 serves to crimp at least the central portion of the heart valve that is secured to the catheter tip 11 of the delivery means 10 during introduction of the catheter tip 11 into the introducer sheath 41. As explained in connection with FIG. 2c, only the distal and proximal end portions of the heart valve are fixed to the catheter tip 11 of the delivery means 10 by the first and second holding means 15, 16 in this case. There is no dedicated holding means assigned to the central portion of the heart valve between the distal and proximal end portions of the heart valve.

  To crimp the central portion of the heart valve during introduction of the catheter tip 11 into the introducer sheath 41, the catheter tip 11 passes through the crimping portion 45 of the introducer 40 and is thereby secured to the catheter tip 11. The diameter of the central part of the valve is further reduced. As shown in FIG. 4, the crimping portion 45 may comprise a conical tubular member that has an inner diameter that decreases in a distal direction of the tubular member.

  The introducer sheath 41 may be made of a thin material so as to allow bending of the introducer sheath 41 to follow a tortuous path from the femoral artery to the implantation site. However, the introducer sheath 41 material should be sufficiently rigid to mechanically avoid kinking of the flexible portion of the distal portion of the catheter shaft 12 during insertion of the catheter tip 11.

  Inlets 1, 1 ′, 1 ″ may be provided at the proximal end portion of the steering means 30, the introducer 40, and / or the delivery means 10 for injecting fluid as required. A check valve may be provided at the proximal end portion of the introducer sheath 41 to prevent fluid from leaking out of the introducer sheath 41.

  The introducer sheath 41 may have a length sufficient to protect the inner wall of the blood vessel through which the catheter tip 11 passes. In addition, a separate introduction system (not belonging to the catheter system) may be provided. At this time, the introduction system may serve as an introduction unit for passing the entire catheter system from the catheter tip 11 to the catheter shaft 12 into the patient's body up to the heart.

  In addition, the introducer sheath 41 reduces the compressive force exerted on the first catheter tube inserted through the introducer sheath 41. This enhances the mobility of the steerable catheter tube 31 and the catheter shaft 12 of the delivery means 10 throughout the procedure. The result is that any frictional force is reduced. Furthermore, moving the catheter tip 11 after it has been pushed through the patient's vasculature is greatly improved while reducing the risk of injury to the patient.

  As can be appreciated, the introducer sheath 41 is used to move the stent transarterially or via a vein to an inadequate heart valve, allowing insertion into a patient's blood vessel (artery or vein). Size, i.e., has an outer diameter.

  Figures 6a to 6i represent side sectional views of components of the delivery means of Figure 2a.

7-12 represent a further embodiment of the present disclosure.
In one aspect, embodiments of the present disclosure
i) steering means;
ii) Delivery means for an optionally expandable or self-expandable balloon for a heart valve, the steering means and the delivery means being movable coaxially and independently in the direction of rotation Means,
A catheter system comprising:

  In one embodiment, the catheter system is compatible with an introducer for intravascular applications, optionally transfemoral (TF) applications, or transcardiac (TA) of replacement heart valves. It can be modified to be suitable for delivery. In such TA systems and means, the direction in which the cardiac prosthesis is releasably connected with the delivery means is rotated by 180 ° compared to TF applications.

  In some embodiments, a catheter system according to the present disclosure optionally includes an introducer sheath that extends or is extendable through the vascular channel proximal to the target site of the heart. And, optionally, the introducer sheath has a crimping portion.

  The catheter system according to embodiments of the present disclosure has first and second retaining means at the distal end of the catheter system for reversibly securing the heart valve to the delivery means.

  Optionally, the catheter system according to an embodiment of the present disclosure is such that the first retaining means reversibly secures the distal end of the heart valve relative to the delivery means and the second retaining means is near the heart valve. The position end is reversibly fixed to the delivery means.

  In one embodiment, the central portion of the heart valve is not covered by the sleeve means. Thus, this central portion is still flexible in terms of diameter and the tissue is not pressurized by a crimping procedure that provides tension to the pericardial valve material. In this way, only the heart valve is crimped during the deployment procedure, and thus the time during which the replacement heart valve is crimped to its minimum diameter is kept relatively short.

  Thus, in at least one embodiment of the catheter system according to the present disclosure, the diameter of the fixed heart valve varies over its length, and preferably the heart valve extends over its length to the inner diameter of the introducer sheath. It can be compressed.

  Thus, in at least one embodiment of the catheter system according to the present disclosure, the inner diameter when the introducer sheath can be selected as required by the respective application is less than 24 French, such as less than 20 French, 18 French. Less than or even less than 16 French.

  In at least one embodiment, the introducer sheath has a preformed form, preferably a curved form.

  As will be appreciated by those skilled in the art, materials commonly applied in catheters and delivery systems can also be used in embodiments according to the present disclosure. For example, in a catheter system according to embodiments of the present disclosure, the introducer sheath is characterized by a flexible polymer, a hydrophilic coating, a PTFE liner, a coil reinforcement and / or a braid reinforcement.

  The replacement heart valve may be attached to the delivery means by useful means compatible with other parts of the device. In one embodiment, the heart valve is attached to the delivery means by a securing means, in which case the heart valve and the delivery means have complementary shapes. For example, the heart valve may have male connector elements at the distal and proximal ends for engaging the female connector element of the delivery means.

  In at least one embodiment according to the present disclosure in a catheter system, the delivery means and the steering means are operated by one or two means, optionally one or two handles. The steering means may comprise means for deflecting the delivery catheter shaft from a relaxed configuration to a curved configuration.

  In at least one embodiment of the catheter system according to the present disclosure, the delivery means and the steering means can be releasably connected.

  In other aspects, embodiments of the present disclosure include: i. Steering means, ii. Delivery means for a heart valve; and iii. The present invention relates to a delivery system for a heart valve comprising an introducer sheath, the steering means, the delivery means and the introducer sheath being coaxially and independently movable in the circumferential direction.

  In an exemplary embodiment, the introducer sheath optionally extends or is extendable through the vascular channel proximal to the heart.

  Different parts or parts of the delivery system may be adapted to each other and may be formed such that these parts or parts fit in their structural and functional characteristics. In at least one embodiment, the steering means, the delivery means, and the introducer sheath are at least partially, partially, or almost completely disposed coaxially with each other. The steering means, the delivery means, and the introducer sheath may be movable coaxially and independently in the rotational direction.

  In delivery systems according to some embodiments of the present disclosure, delivery means and steering means can be introduced into the introducer sheath simultaneously or independently.

  In the delivery system according to embodiments of the present disclosure, the introducer sheath can have a crimping portion for reducing the diameter of the heart valve attached to the delivery means. Such a crimping portion has the advantage that only the replacement heart valve is crimped over its entire length to its minimum diameter during the delivery and deployment procedure, thereby causing little stress effect on the pericardial tissue of the replacement heart valve. Have.

  In another aspect, an embodiment of the present disclosure is a method for delivering a heart valve to a patient's heart comprising: i. Placing an introducer comprising an introducer sheath into a patient's vasculature; ii. A second step of introducing a self-expanding or balloon expandable catheter system having a fixed heart valve through the introducer into the patient's vasculature; iii. Positioning a heart valve proximal to a target site in the patient's heart, optionally positioning the heart valve approximately midway in the target area; iv. A fourth step of positioning the heart valve at the target site; v. A fifth step of partially releasing the heart valve from the catheter system; vi. And a sixth step of completely releasing the heart valve from the catheter system.

  In some methods according to embodiments of the present disclosure, at least one segment of the self-expanding heart valve has a first diameter when the self-expanding heart valve is passed through the introducer sheath, preferably through the crimping portion. To a second diameter smaller than the first diameter.

  In another aspect of the disclosed embodiment, at least one segment of the self-expanding heart valve is greater than the first diameter from the first diameter when the self-expanding heart valve exits the distal end of the introducer sheath. Also expands to a larger second diameter.

In other aspects, embodiments of the present disclosure are self-expanding with respect to the delivery means of the catheter system having at least one shaft and at least one outer sheath and / or characterized as described above throughout the specification. Or a method of loading a balloon expandable heart valve, comprising:
-Radially compressing the heart valve and disposing the compressed heart valve within the tubular holder, wherein the holder prevents the self-expanding valve from expanding radially;
-Passing the inner shaft of the delivery system through the central opening of the compressed heart valve;
-Attaching the distal tip to the shaft of the delivery system;
-Forcing the outer sheath over the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
-Removing the tubular retainer from the compressed self-expanding heart valve;
Or a method comprising these steps.

  In the following, further alternative and / or exemplary embodiments will be described.

  In at least one embodiment, the present disclosure relates to a delivery system for a prosthesis, eg, a heart valve, which delivery system generally consists of or comprises three components. Each of the three components consists of a handle, and each handle is characterized by additional parts as follows:

  The port handle comprises a preformed tubular component that can be introduced through the patient's vasculature, eg, transfemorally, starting from the femoral artery to the proximal side of the heart. This introducer sheath has a length of 50 to 150 cm, for example 100 to 120 cm. The tubular element may have a preformed bend or it may be formed so that it bends easily around the aorta proximal to the heart. A balloon device can be introduced through this handle / introducer sheath, which represents the first step in the prosthesis delivery procedure. This handle has a torsion grip, is positioned on the upper leg and has the function of introducing other components of the delivery system. The tubular component can be pushed through the port handle or secured to the port handle. The tubular component is made of a compatible polymeric material that is reinforced with wire and may include PTFE or Teflon coated on the inside. The port handle may have a valve or other means for closing the hollow inlet tube that serves to introduce the introducer sheath and catheter components of the system. The inner diameter of the introducer sheath is less than 25 French, such as less than 20 French, less than 18 French, or has a diameter of 20, 18 or 16 French.

  The introducer sheath can be coupled to a second handle (introducer sheath handle) that can push the introducer sheath combined with the introducer sheath handle. The introducer sheath handle has a similar means of wire so that the introducer sheath is steerable. In this way, during deployment of the prosthesis, the introducer sheath can be bent or oriented at a predetermined location that facilitates the deployment procedure. The first and second handles can have means for releasably connecting them to each other.

  The third handle corresponds to the catheter component of the delivery system. The third handle includes a handle, a catheter shaft, a distal capsule for releasably connecting the prosthesis, and a flushing tube including closure means. The handle has control means for connecting and releasing the prosthesis.

  Any component or all components can be introduced by a guide wire.

  The delivery procedure may follow the step of opening the femoral vasculature and introducing a port and / or guide wire as an access. The port handle and introducer sheath are positioned on the upper leg and are introduced up the aorta. In the next step, a balloon device is introduced through the port and introducer sheath to expand the target site by balloon expansion. After this operation is performed, the balloon device is recovered. In the next step, a catheter is introduced through the introducer sheath. A prosthesis is preloaded in the distal capsule on the catheter. The prosthesis is connected at both ends at a predetermined mounting position corresponding to a male / female connection that allows stepwise controlled release of the prosthesis at the target site. Thus, the prosthesis is connected to the catheter so that the connection corresponds to a small diameter, otherwise the prosthesis is not connected and is not covered by a sheath or other dressing. Thus, the diameter of this central portion of the prosthesis is due to greater outward tension of the stent material than at the connection site. The advantage of this configuration is that a small diameter of the loaded prosthesis can be achieved. In the process of introducing the prosthesis loaded onto the catheter capsule into and through the introducer sheath, the prosthesis is crimped to its final diameter that is predefined by the inner diameter of the introducer sheath. The material form of the introducer sheath facilitates crimping and also facilitates advancement through the sheath.

  At this time, the prosthesis can be brought closer to the target site using the introducer sheath and the catheter. Another advantage of the delivery system is that both the catheter and introducer sheath can be moved coaxially and independently in the direction of rotation. Also, the introducer sheath can be bent by the steering means of the second handle, thus facilitating manipulation of the prosthesis toward its final target site through the vasculature. Another advantage of the system according to embodiments of the present disclosure is that the catheter handle and the second handle of the introducer sheath with steering means can be moved and operated independently.

  The release procedure can be managed by a reversible two-step process. The release process begins when the prosthetic feeler is placed in the leaflet of the natural aortic valve. In the first step, the proximal connecting means is pushed in the forward / proximal direction. This releases the proximal end of the prosthesis. The prosthetic catheter may have visualization means for better visual control. In the second step, the distal connection means is retracted or pulled back by the control means of the catheter handle to release the distal end of the prosthesis and remove the entire prosthesis from the catheter. The control means can be designed as an independent means for each connection means or as a connected aspect.

  Thus, the advantages of the embodiments of the present disclosure are achieved by prosthesis loading, particularly crimping of the prosthesis, by the introducer sheath so that the crimping procedure is combined with the introduction of the prosthesis into the vasculature to facilitate the process. It is that. This suggests the advantage that a separate cover means for pre-crimping the prosthesis is consequently unnecessary and the further advantage that the prosthetic tissue is crimped more smoothly and not too hard. This suggests a low risk of damage to the tissue. Also, the crimping procedure is facilitated and the central portion of the prosthesis, usually the thickest part of the valve prosthesis, does not need to be crimped by a special device or by hand. Another advantage is a steering mechanism that is independent of the catheter handle. The extension of the port by the introducer sheath for delivery of the cardiac prosthesis is novel and has the advantages described above.

  A further advantage is that the bending can be managed independently of the delivery capsule. Thus, all parts such as ports, handles, capsules, steerable means and prostheses can move completely independently and can move coaxially and rotationally, so that the prosthesis at the target site Is easy to deploy. Furthermore, the prosthesis may be deployed by a two-stage procedure and is repositionable. Also, the procedure may be interrupted during the delivery procedure.

  The combination of the different components of the delivery system may help to achieve certain advantages and superior delivery, and is provided in a manner that is simple and secure to deploy.

  Release of the heart valve prosthesis from the delivery means can be accomplished in a two-stage deployment method.

  As will be appreciated by those skilled in the art, catheter systems, delivery systems, methods for loading, and methods for delivering heart valves to the heart can be used to position target sites in the heart for deployment of replacement heart valve prostheses. It may be combined with suitable apparatus and methods or steps for pretreatment. Thus, a balloon device or system can be applied prior to delivery of the replacement heart valve to expand the target site within the heart. The system may be introduced by a port and / or introducer sheath according to embodiments of the present disclosure, thereby allowing the port and introducer sheath to be transfemorally located at the patient's vascular inlet. In addition, there is an advantage that only one access is required to expand the target site by balloon expansion. After the balloon device is retrieved, a replacement prosthesis can be applied as described above.

  The introduced parts and devices can be guided by guidewires known in the art and are formed from materials as commonly applied in the art.

  It may be beneficial if the tip of the catheter device is made of a material that can be formed from a flexible or semi-rigid material and / or bendable to easily pass through the patient's vasculature. Known materials can be used for such flexible tips.

  Not only does the combination of an introducer sheath and delivery catheter component according to embodiments of the present disclosure simplify the loading and delivery procedure, but also requires few layers of heart valve prosthesis coating, and thus the diameter and crimping diameter. It is emphasized that there is also the advantage that the force applied to the prosthesis can be influenced in an advantageous manner. As such, it can be expected to have less impact compared to conventional devices and loading procedures, which suggests the advantage of less replacement heart valve damage and longer replacement heart valve life.

  Given the specific structural characteristics of the delivery device and various catheters according to embodiments of the present disclosure, it can be said that the delivery procedure is a two step process. The first step is placement of the port and introducer sheath and loading of the replacement heart valve, and the second step is the deployment of the heart valve relative to the target site. The deployment itself involves a first release step of a portion of the replacement heart valve and a second step that is final and complete release of the replacement heart valve and final positioning of the replacement heart valve with respect to the target site. It is a series of two steps. Between these steps, recovery of the replacement heart valve is still possible, giving the option of repositioning, complete recovery, and discontinuing the deployment procedure.

  According to one aspect, the present disclosure provides a catheter system for introducing an expandable heart valve into a patient's body, the catheter system comprising delivery means for the heart valve.

  In some aspects of the present disclosure, the delivery means comprises a catheter tip and a catheter shaft. The catheter tip of the delivery means has a seat for receiving the heart valve to be introduced into the patient's body in its folded or crimped state. The catheter tip further comprises a securing means for releasably securing the heart valve to the catheter tip.

  The seat portion of the catheter tip is constituted by first holding means and second holding means. In some embodiments of the present disclosure, the first holding means and the second holding means may be constituted by a first sleeve-shaped member and a second sleeve-shaped member.

  The first holding means of the catheter tip serves to reversibly fix the distal end portion of the heart valve to the delivery means, in particular to the catheter tip of the delivery means. On the other hand, the second holding means of the catheter tip serves to reversibly fix the proximal end portion of the heart valve to the delivery means, in particular to the catheter tip of the delivery means.

  The first and second holding means are movable relative to each other and are also movable relative to the catheter tip fixing means.

  According to some embodiments of the present disclosure, the catheter shaft of the delivery means comprises a first force transmission means and a second force transmission means.

  The distal end portion of the first force transmitting means is connected to or connectable to the first holding means of the catheter tip, and the proximal end portion of the first force transmitting means is that of the delivery means. Connected to or connectable to the first operating means of the handle. The distal end portion of the second force transmitting means is connected to or connectable to the second holding means of the catheter tip, and the proximal end portion of the second force transmitting means is Connected to or connectable to the second operating means of the handle.

  According to some embodiments of the present disclosure, the handle of the delivery means has at least one first operating means and at least one second operating means, using these operating means to the catheter tip. The catheter tip of the delivery means can be appropriately manipulated so that the fixed expandable heart valve can be released from the catheter tip in stages or in a predetermined or definable sequence of events.

  According to some embodiments of the present disclosure, the catheter tip has first and second retaining means, eg in the form of a sleeve-shaped member, which may be manipulated using the handle of the delivery means. These retaining means are used to releasably and reversibly fix the distal and proximal end portions of the heart valve to the catheter tip.

  In some embodiments of the present disclosure, the first retention means releasably and reversibly secures a first functional component of the heart valve, such as a stent retention hoop or alternatively a stent positioning hoop. While the second retaining means serves to releasably and reversibly fix the second functional component of the heart valve, eg, the positioning hoop of the stent, or alternatively, retain the stent Help accept the hoop.

  With regard to the handle of the delivery means, in some embodiments, on the one hand, such that a predefinable longitudinal movement of the first holding means can be brought with respect to the fixing means upon actuation of the first operating means. It is preferably provided that the first operating means cooperate with the first holding means of the catheter tip. On the other hand, the second operating means cooperates with the second holding means of the catheter tip so that a predefinable longitudinal movement of the second holding means can be effected relative to the fixing means.

  According to some embodiments of the present disclosure, the first and second retaining means serve only to secure the distal and proximal end portions of the heart valve to the catheter tip. Where the first and second retaining means are configured as first and second sleeve-shaped members, these sleeve-shaped members are used to secure the distal and proximal end portions of the heart valve to the catheter tip. The first and second sleeve-shaped members have such a length that there is a gap between them.

  According to some embodiments of the present disclosure, the first force transmission means of the delivery means is constituted by a first catheter tube defining a first lumen, and the second force transmission means of the delivery means. Is constituted by a second catheter tube defining a second lumen. The second catheter tube has a cross section that is smaller than the cross section of the first catheter tube. The first catheter tube is disposed concentrically and coaxially with the second catheter tube, and the second catheter tube is received within a first lumen defined by the first catheter tube.

  However, unlike the first and second sleeve-shaped members of the catheter tip, the catheter tip securing means cannot move relative to the handle of the delivery means. Rather, the securing means is connected to the handle of the delivery means by using a securing tube having a distal end connected to the securing means and a proximal end connected to the body of the handle of the delivery means. The fixed tube has a cross section that is smaller than the cross section of the first catheter tube. In particular, the first catheter tube is arranged concentrically and coaxially with both the second catheter tube on the one hand and the stationary tube on the other hand.

  In some embodiments, the fixation tube is received in a first lumen defined by the first catheter tube and a second catheter tube is received in a passage defined by the fixation tube. Thus, it has a cross section that is smaller than the cross section of the first catheter tube and larger than the cross section of the second catheter tube. The passage defined by the fixation tube has a diameter sufficient to receive the second catheter tube so that the second catheter tube can move relative to the fixation tube.

  The second lumen defined by the second catheter tube has a diameter sufficient to receive the guide wire. The second catheter tube is made from a rigid material including, for example, nitinol, stainless steel, or a rigid plastic material. The material of the distal end portion of the second catheter tube is more flexible than the material of the proximal end portion to allow the distal end portion of the catheter shaft to pass through the aortic arch during insertion of the catheter tip. You may have.

  In some embodiments of the present disclosure, the distal end portion of the second catheter tube terminates with a flexible catheter end tip having an atraumatic shape. The flexible catheter end tip includes a second lumen and position defined by the second catheter tube so that a guidewire received within the second lumen of the second catheter tube can pass through the channel of the flexible catheter end tip. Matched channels are provided. The second sleeve-shaped member of the catheter tip is a flexible catheter such that the open end of the second sleeve-shaped member is oriented in the proximal direction opposite the flexible catheter end tip and the second catheter tube. Connected to end chip.

  In some embodiments, the fixation tube is made from a hard material, such as a hard plastic material, stainless steel, or Nitinol. The distal end of the fixation tube terminates with a fixation means, which is also made from a hard material, such as a hard plastic material or stainless steel. The passage defined by the fixation tube is aligned with the channel passing through the fixation means. In this way, the second catheter tube is received in the passage of the fixation tube and in the channel of the fixation means so that it can move relative to the fixation tube and the fixation means.

  A securing tube is provided for connecting the securing means to the handle of the delivery means. For this purpose, the fixation tube has a distal end connected to the fixation means and a proximal end connected to the body of the handle of the delivery means.

  In some embodiments, the first catheter tube is preferably made of a material that can be bent but is axially rigid. For example, the first catheter tube may be made at least partially from a knitted or non-knitted catheter tube. As such, the first catheter tube may have a highly rigid knitted reinforcement similar to the catheter body described in US Pat. No. 4,665,604, incorporated herein by reference. Good.

  The first catheter tube is adapted to transmit compressive and tensile forces from the first operating means of the handle of the delivery means to the first holding means of the catheter tip without unduly changing its overall length. It shall be. The distal end of the first catheter tube terminates in an overhanging portion as a transition to the portion defining the first retaining means of the catheter tip.

  The overhanging portion and the first retaining means may be integrally formed and may be connected to the distal end portion of the first catheter tube.

  Alternatively, the first retaining means and the overhanging portion of the first catheter tube are all made of the same material so that the overhanging portion and the first holding means are the same element, and the same raw tube before the expansion process May be produced from

  According to another aspect of the present disclosure, the catheter system further comprises steering means. The steering means is for guiding the delivery means, in particular the catheter tip of the delivery means, as it is pushed through the patient's vasculature.

  In some embodiments of the present disclosure, the steering means comprises a steerable catheter tube having a proximal end portion and a distal end portion. The proximal end portion of the steerable catheter tube is connected or connectable with the handle of the steering means.

  The steering means handle is provided with operating means, for example in the form of a rotatable knob or wheel, which can be used to control the bendable link region of the steerable catheter tube.

  According to other embodiments disclosed herein, the material of the distal end portion of the steerable catheter tube may be more flexible than the material of the proximal end portion. . In this way, the distal end portion of the steerable catheter tube can easily pass, for example, the aortic arch during insertion of the steerable catheter tube.

  In some embodiments disclosed herein, the steering means handle is provided with an operating means capable of controlling a bendable link region of the steerable catheter tube, wherein the operating means is It is preferable to have a detent device to allow the set deflection of the bendable link region of the steerable catheter tube to be fixed. For example, the operating means can be provided with a suitable catch mechanism that cooperates with the body of the steering means handle. In particular, the bending link region of the steerable catheter tube can be connected to the operating means of the steering means by means of a control wire, so that when the operating means is activated, the bending link region is pre-defined via the control wire. A tensile force that causes a deformed or predefinable deflection is exerted on the bendable link region of the steerable catheter tube.

  However, of course, in the case where such a bendable link region is provided in the steerable catheter tube, the steerable catheter tube, or the steering means for deflecting the bendable link region of the steerable catheter tube Other embodiments can be selected as the operation means.

  According to some embodiments disclosed herein, the proximal end portion of the steerable catheter tube of the steering means terminates at the port portion of the steering means or the steering means It is connected with the port part. The port portion of the steering means serves to introduce the catheter tip and catheter shaft of the delivery means into the steerable catheter tube. For this purpose, the port portion of the steering means has a lumen defining a passage extending through the port portion, the distal end portion of the passage being the proximal end of the steerable catheter tube 31. Aligned with the part.

  In some embodiments, the port portion of the steering means is preferably incorporated into or connected to the steering means handle.

  The catheter tip and catheter shaft of the delivery means can be introduced into the steering catheter tube (via the port portion of the steering means). The catheter shaft of the delivery means, in particular the first catheter tube of the catheter shaft of the delivery means, is movable relative to the steerable catheter tube. In particular, the steerable catheter tube terminates proximally of the catheter tip, in which case the cross-section of the proximal end portion of the introducer sheath is of an overhang portion provided at the proximal end of the first catheter tube. It shall be approximately the same as the cross section or slightly larger than this cross section.

  The proximal end portion of the steering means, in particular the proximal end portion of the port portion of the steering means, can be releasably connected to the handle of the delivery means.

  According to one aspect of the present disclosure, the catheter system further comprises an introducer having an introducer sheath. The introducer sheath has a cross section that is larger than the cross section of the steerable catheter tube of the steering means.

  The introducer sheath serves as a guiding means for introducing the delivery means and / or the steering means, in particular the steerable catheter tube of the steering means into the patient's vasculature. More particularly, the introducer sheath defines a passageway through which the catheter tip and catheter shaft of the delivery means and / or the steerable catheter tube of the steering means are guided to the implantation side in the patient's body. Also good.

  The introducer sheath has a distal end, a proximal end, and a passage extending between the distal end and the proximal end. The introducer sheath is such that the distal end of the introducer sheath terminates proximal to the catheter tip of the delivery system when the catheter shaft and catheter tip of the delivery system are fully introduced into the introducer sheath. Length.

  Once at least a portion of the catheter shaft of the delivery means or at least a portion of the steerable catheter tube of the steering means has been introduced into the passage defined by the introducer sheath, the introducer sheath becomes the catheter shaft of the delivery means. Or that portion of the steering means is arranged concentrically and coaxially with that portion of the steerable catheter tube.

  However, in any case, the catheter shaft of the delivery means and / or the steerable catheter tube of the steering means can move relative to the introducer sheath. In particular, the introducer sheath terminates proximal to the catheter tip, in which case the cross-section of the proximal end portion of the introducer sheath is approximately the same as or slightly less than the cross-section of the steerable catheter tube. To be large.

  The proximal end portion of the introducer sheath is connected to the introducer port. The introducer port serves to provide access to the introducer sheath of the introducer that is required to deliver the steerable catheter tube of the delivery means or steering means into the introducer sheath.

  The introducer port can be manually secured to the handle of the delivery means when the catheter shaft of the delivery means is introduced into the passage defined by the introducer sheath, or the steerable catheter tube of the steering means A base member may be provided that is configured to be manually secured to the steering means handle when the is introduced into the passage defined by the introducer sheath.

  According to some embodiments disclosed herein, the introducer port provides fluid, particularly blood leakage, from the introducer when the introducer sheath is introduced into the patient's vasculature. A seal structure is provided to prevent this.

  In some embodiments, the proximal end portion of the introducer sheath terminates in a crimping portion distal to the introducer port seal structure. The crimping portion of the introducer serves to crimp at least the central portion of the heart valve that is secured to the catheter tip of the delivery means during introduction of the catheter tip into the introducer sheath. As already mentioned above, according to the embodiments disclosed herein, preferably only the distal and proximal end portions of the heart valve are catheters of the delivery means by the first and second retaining means. There is no dedicated holding means that is fixed to the tip and in this case assigned to the central part of the heart valve between the distal and proximal end parts of the heart valve.

  The diameter of the central portion of the heart valve that is passed through the crimping portion of the introducer and thereby secured to the catheter tip to crimp the central portion of the heart valve during introduction of the catheter tip into the introducer sheath Is further reduced. In some embodiments disclosed herein, the crimping portion may comprise a conical tubular member, the conical tubular member having an inner diameter that decreases in a distal direction of the tubular member.

  The introducer sheath may be made of a thin material so as to allow for length deformation of the introducer sheath upon transmission of compressive and tensile forces. However, the introducer sheath material should be sufficiently rigid to mechanically avoid kinking of the flexible portion of the distal portion of the catheter shaft during insertion of the catheter tip.

  In some embodiments of the present disclosure, the introducer sheath has a preformed configuration, preferably a curved configuration.

  An inlet may be provided at the proximal end portion of the steering means, introducer, and / or delivery means to inject fluid as needed. In addition, a check valve may be provided at the proximal end portion of the introducer sheath to prevent fluid from leaking out of the introducer sheath.

  The introducer sheath may have a length sufficient to protect the inner wall of the blood vessel through which the catheter tip passes. In addition, a separate introduction system (not belonging to the catheter system) may be provided. At this time, the introduction system may serve as an introduction unit for passing the entire catheter system from the catheter tip to the catheter shaft into the patient's body up to the heart.

  In addition, the introducer sheath reduces the compressive force exerted on the first catheter tube inserted through the introducer sheath. This enhances the mobility of the steerable catheter tube and the catheter shaft of the delivery means throughout the procedure. The result is that any frictional force is reduced. Furthermore, moving the catheter tip after it has been pushed through the patient's vasculature is greatly improved while reducing the risk of injury to the patient.

  The length of the introducer sheath depends on the length of the catheter shaft of the delivery means and is generally about 20 cm to 60 cm for transaortic (TA) access and transfemoral (TF). In the case of simple access, it is 80 cm to 150 cm. However, as will be appreciated by those skilled in the art, all dimensions given herein are intended as an example only, and for certain applications, different dimensions of introducer sheath and It may be replaced by a catheter tube.

  As can be appreciated, the introducer sheath allows for insertion into the patient's blood vessels (arteries or veins) used to move the stent transarterially or via a vein to an inadequate heart valve. Size, i.e., has an outer diameter.

  The introducer sheath may be able to traverse a tortuous path in the patient's body without kinking. The introducer sheath may include an inner smooth liner, an outer polymeric jacket, and a coil reinforcement between the inner and outer layers. This introducer sheath can provide advantageous flexibility without kinking or compression. One or more radiopaque bands or markers may be incorporated into the introducer sheath material to allow accurate positioning of the distal end of the introducer sheath for positioning accuracy. As known to those skilled in the art, other known materials may be suitable for a particular purpose.

The catheter system is particularly adapted to deliver and implant a heart valve as described, for example, in European Patent Application No. 07 110 318 or European Patent Application No. 08 151 963. Accordingly, in some embodiments of the present disclosure, a heart valve is used that includes a stent and a heart valve prosthesis attached to the stent. A stent has the following elements:
A first holding region to which a heart valve prosthesis can be attached;
The fixation of the catheter tip of the delivery means to the opposite second holding region with at least one holding element, for example in the form of a holding eye or in the form of a holding head. A second holding region that can be in releasable engagement with the means;
-At least one retention hoop capable of fastening the heart valve prosthesis;
-At least one positioning hoop formed to engage within the pocket of the natural heart valve in the implanted state of the stent and thus to allow automatic positioning of the stent within the patient's aorta In some embodiments, preferably three positioning hoops;
Have

  In particular, in the present description, an expandable heart valve stent is attached to the stent in a particularly simple manner, for example via the aorta of the patient to be treated (transarterially or transfemorally). A catheter system that can be pushed to an implantation site with a heart valve prosthesis attached is disclosed. In some embodiments, the catheter tip provided in the distal end region of the catheter system that can receive the stent with the heart valve prosthesis can be made sufficiently small relative to the outer diameter of the catheter, such that Or, during transfemoral access, the total free cross section available in the aorta is not completely filled.

  The expandable heart valve stent can be temporarily secured in a crimped state to the catheter tip of the delivery means during implantation with the heart valve prosthesis attached to the stent.

  Accordingly, a catheter system that is configured for transarterial or transfemoral access has a heart valve stent that is transarterially or transfemorally articulated with the heart valve prosthesis attached to the stent. Suitable for insertion into the body, for example, the catheter tip of the delivery means of the catheter system is inserted by puncture of the femoral artery (inguinal artery).

  In particular, if the catheter system is configured for transarterial or transfemoral access, the catheter shaft of the delivery means may be configured such that it has both kink resistance and flexibility, Thereby, a bending radius of at most 4 cm, for example at most 3 cm, can be achieved at least in the distal end region of the catheter shaft.

  Hereinafter, exemplary embodiments will be described with reference to the accompanying drawings.

In the following sections, further alternative and / or exemplary aspects of the present disclosure are illustrated.
1. An improved system for delivering a self-expanding implant comprising an introducer sheath and a delivery catheter to an implantation site within a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site,
The delivery catheter has first and second retaining means at the distal end of the delivery catheter for reversibly securing the implant to the delivery catheter;
The first retaining means reversibly secures the distal end of the self-expanding implant to the delivery catheter, and the second retaining means reversibly secures the proximal end of the self-expanding implant to the delivery catheter;
A delivery catheter is threaded through the introducer sheath to deliver the self-expanding implant to the implantation site;
The central portion of the self-expanding implant is compressed from a first diameter to a second diameter smaller than the first diameter when the self-expanding implant is passed through the introducer sheath.
Improved system.
2. The system according to aspect 1, wherein the implant is at least one of a stent, a stent graft, and a heart valve prosthesis.
3. The system of aspect 1, wherein the implant has male connector elements at the distal and proximal ends for engaging with female connector elements on the delivery catheter.
4). 4. The system of embodiment 3, wherein the male connector element is an eyelet and the female element is a recess in the delivery catheter.
5. The system of embodiment 1, wherein the introducer sheath has a hemostasis valve at the proximal end.
6). The system of aspect 1, wherein the retaining means comprises an axially movable sheath that at least partially restricts radial expansion of the implant.
7). A process for delivering a self-expanding implant to an implantation site in a blood vessel, comprising:
Inserting an introducer sheath from outside the body into a blood vessel through an opening in the body;
Positioning the distal end of the introducer sheath near the implantation site;
Reversibly securing the distal and proximal ends of the self-expanding implant to the distal end of the delivery catheter;
Inserting the delivery catheter into the introducer sheath with the self-expanding implant secured to the delivery catheter, wherein the first portion is inserted when the central portion of the self-expanding implant is inserted into the introducer sheath. Compressing from a diameter to a second diameter; and
Pushing the delivery catheter through the introducer sheath until the self-expanding implant exits the distal end of the introducer sheath;
Releasing the distal and proximal ends of the self-expanding implant from the delivery catheter at the implantation site;
A process involving a combination of
8). A system for delivering an implant consisting of an introducer sheath, a delivery catheter, and a biasing member to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site,
The delivery catheter has retention means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member has means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
A delivery catheter is threaded through the introducer sheath to deliver the implant to the implantation site;
The biasing member can move axially and rotationally relative to the introducer sheath and delivery catheter inside the introducer sheath.
system.
9. 9. The system of aspect 8, wherein the implant is a self-expanding or balloon expandable heart valve prosthesis.
10. The system according to aspect 9, wherein the implantation site is a natural aortic valve or a natural mitral valve.
11. 11. A system according to any one of aspects 1 to 10, wherein the introducer sheath has a preformed curved configuration.
12 A system for manipulating an implant consisting of an introducer sheath, a delivery catheter, and a biasing member toward an implantation site in a patient's blood vessel,
The delivery catheter has retention means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member has means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
The delivery catheter is inserted into the introducer sheath and can move axially and rotationally within the introducer sheath,
The biasing member is inserted into the introducer sheath and can move axially and rotationally within the introducer sheath and can move axially and rotationally relative to the delivery catheter.
A system with a combination of things.
13. A method of positioning an implant toward a target site in a blood vessel,
Inserting an introducer sheath from outside the body into a blood vessel through an opening in the body;
Positioning the distal end of the introducer sheath near the implantation site;
Reversibly securing the implant to the distal end of the delivery catheter;
Placing a biasing member on the shaft of the delivery system having means for actively deflecting the shaft of the delivery system from a relaxed configuration to a curved configuration;
Inserting a delivery catheter with the implant and biasing member into the introducer sheath;
Pushing the delivery catheter through the introducer sheath until the implant exits the distal end of the introducer sheath; and
Adjusting the position of the biasing member in the introducer sheath in the axial and rotational directions;
Actuating the biasing member to deflect the shaft of the delivery system into the desired bending configuration;
Axially adjusting the position of the delivery system to place the implant at the target site;
Releasing the implant from the delivery system;
Including methods.
14 A method of loading a self-expanding heart valve onto a delivery catheter having an inner shaft, an attachable distal tip, and at least one outer sheath, comprising:
Compressing the self-expanding heart valve radially and placing the compressed self-expanding heart valve into the tubular retainer, the retainer preventing the self-expanding valve from expanding radially , Steps and
Passing the inner shaft of the delivery system through the central opening of the compressed self-expanding heart valve;
Attaching the distal tip to the inner shaft of the delivery system;
Forcing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
Removing the tubular retainer from the compressed self-expanding heart valve;
Including methods.
15. i. Steering means; ii. Optionally, a balloon expandable or self-expandable delivery means for a heart valve, the steering system and the delivery means being coaxially and independently movable in the rotational direction.
16. 16. The catheter system of aspect 15, wherein the system is compatible with an introducer for intravascular applications, optionally transfemoral applications.
17. 17. The catheter system of aspect 16, wherein the introducer optionally comprises an introducer sheath that extends or is extendable through the vascular channel proximal to the target site of the heart.
18. A catheter system according to aspect 15 or 16, comprising first and second retaining means at the distal end of the catheter system for reversibly securing the heart valve to the delivery means.
19. The first holding means reversibly fixes the distal end of the heart valve to the delivery means, and the second holding means reversibly fixes the proximal end of the heart valve to the delivery means. The catheter system according to claim 18.
20. The catheter system according to any one of aspects 1 to 19, wherein the heart valve is compressible to the inner diameter of the introducer sheath.
21. 21. The catheter system of aspect 20, wherein the inner diameter of the introducer sheath is less than 24 French, preferably less than 20 French, more preferably less than 18 French, and even more preferably less than 16 French.
22. The catheter system according to any one of aspects 1 to 21, wherein the introducer sheath has a preformed curved configuration.
23. The heart valve has a male connector element at the distal and proximal ends for engaging the female connector element of the delivery means.
24. A catheter system in which the delivery means and the steering means are operated by one or two means, optionally one or two handles, in operative relation to the preformed introducer sheath.
25. 16. The catheter system of aspect 15, wherein the steering means comprises means for deflecting the delivery catheter shaft from a relaxed configuration to a curved configuration.
26. A delivery system for a heart valve comprising: i. Steering means; ii. Delivery means for a heart valve; iii. A delivery system comprising an introducer sheath, the steering means, the delivery means, and the introducer sheath being coaxially and independently movable in the circumferential direction.
27. 29. The delivery system of aspect 28, wherein the introducer sheath optionally extends or is extendable through the vascular channel proximal to the heart.
28. A method for delivering a heart valve to a patient's heart comprising the steps of: i. In a first step, an introducer comprising an introducer sheath is placed into the patient's vasculature; ii. In a second step, a catheter system comprising a self-expanding heart valve fixed is introduced through the introducer into the patient's vasculature, iii. In a third step, positioning the self-expanding heart valve proximal to the target site in the patient's heart, optionally positioning the heart valve approximately in the center of the target site; iv. In a fourth step, positioning the self-expanding heart valve at the target site; In a fifth step, the self-expanding heart valve is partially released from the catheter system, vi. In a sixth step, the self-expanding heart valve is completely released from the catheter system.
29. The self-expanding heart valve according to aspect 31, wherein the self-expanding heart valve is compressed from a first diameter to a second diameter smaller than the first diameter when the self-expanding heart valve is passed through the introducer sheath. Method.
30. A method of loading a self-expanding heart valve onto a delivery means of a catheter system having an inner shaft, an attachable distal tip, and at least one outer sheath, comprising:
Compressing the self-expanding heart valve radially and placing the compressed self-expanding heart valve into the tubular retainer, the retainer preventing the self-expanding valve from expanding radially , Steps and
Passing the inner shaft of the delivery system through the central opening of the compressed self-expanding heart valve;
Attaching the distal tip to the inner shaft of the delivery system;
Forcing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
Removing the tubular retainer from the compressed self-expanding heart valve;
A method consisting of:
31. A system for delivering a self-expanding implant comprising an introducer sheath and a delivery catheter to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site,
The delivery catheter has first and second retaining means at the distal end of the delivery catheter for reversibly securing the implant to the delivery catheter;
The first retaining means reversibly secures the distal end of the self-expanding implant to the delivery catheter, and the second retaining means reversibly secures the proximal end of the self-expanding implant to the delivery catheter;
A delivery catheter is threaded through the introducer sheath to deliver the self-expanding implant to the implantation site;
The central portion of the self-expanding implant is compressed from a first diameter to a second diameter smaller than the first diameter when the self-expanding implant is passed through the introducer sheath.
system.
32. 36. The system of aspect 35, wherein the implant is a stent, a stent graft, and a heart valve prosthesis.
33. 36. The system of aspect 35, wherein the implant has male connector elements at the distal and proximal ends for engaging with female connector elements on the delivery catheter.
34. 38. The system of aspect 37, wherein the male connector element is an eyelet and the female element is a recess in the delivery catheter.
35. 36. The system of embodiment 35, wherein the introducer sheath has a hemostasis valve at the proximal end.
36. 36. A system according to aspect 35, wherein the retaining means comprises an axially movable sheath that at least partially restricts radial expansion of the implant.
37. A method of delivering a self-expanding implant to an implantation site in a blood vessel, comprising:
Inserting an introducer sheath from outside the body into a blood vessel through an opening in the body;
Positioning the distal end of the introducer sheath near the implantation site;
Reversibly securing the distal and proximal ends of the self-expanding implant to the distal end of the delivery catheter;
Inserting the delivery catheter into the introducer sheath with the self-expanding implant secured to the delivery catheter, wherein the first portion is inserted when the central portion of the self-expanding implant is inserted into the introducer sheath. Compressing from a diameter to a second diameter; and
Pushing the delivery catheter through the introducer sheath until the self-expanding implant exits the distal end of the introducer sheath;
Releasing the distal and proximal ends of the self-expanding implant from the delivery catheter at the implantation site;
Including methods.
38. A system for delivering an implant consisting of an introducer sheath, a delivery catheter, and a biasing member to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site,
The delivery catheter has retention means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member has means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
A delivery catheter is threaded through the introducer sheath to deliver the implant to the implantation site;
The biasing member is movable axially and rotationally relative to the introducer sheath and the delivery catheter inside the introducer sheath.
system.
39. 39. The system of aspect 38, wherein the implant is a self-expanding or balloon expandable heart valve prosthesis.
40. 39. The system according to aspect 38, wherein the implantation site is a natural aortic valve or a natural mitral valve.
41. 40. A system according to aspect 39, wherein the introducer sheath has a preformed curved configuration.
42. A system for manipulating an implant consisting of an introducer sheath, a delivery catheter, and a biasing member toward an implantation site in a patient's blood vessel,
The delivery catheter has retention means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member has means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
The delivery catheter is inserted into the introducer sheath and is movable axially and rotationally within the introducer sheath;
The biasing member is inserted into the introducer sheath and is movable in the axial direction and the rotational direction in the introducer sheath, and is movable in the axial direction and the rotational direction with respect to the delivery catheter.
system.
A method of positioning an implant toward a target site in a blood vessel, comprising the step of inserting an introducer sheath from outside the body through a body opening into the blood vessel,
Installation is
Placing the distal end of the introducer sheath near the implantation site;
Reversibly fix the implant to the distal end of the delivery catheter;
Placing a biasing member on the shaft of the delivery system having means for actively deflecting the shaft of the delivery system from a relaxed configuration to a curved configuration;
Inserting the delivery catheter with the implant and biasing member into the introducer sheath;
A method achieved by pushing the delivery catheter through the introducer sheath until the implant exits the distal end of the introducer sheath.
43. A method of loading a self-expanding heart valve onto a delivery catheter having an inner shaft, an attachable distal tip, and at least one outer sheath, comprising:
Compressing the self-expanding heart valve radially and placing the compressed self-expanding heart valve into the tubular retainer, the retainer preventing the self-expanding valve from expanding radially , Steps and
Passing the inner shaft of the delivery system through the central opening of the compressed self-expanding heart valve;
Attaching the distal tip to the inner shaft of the delivery system;
Forcing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
Removing the tubular retainer from the compressed self-expanding heart valve;
Adjusting the position of the biasing member in the introducer sheath in the axial and rotational directions;
Actuating the biasing member to deflect the shaft of the delivery system into the desired bending configuration;
Axially adjusting the position of the delivery system to place the implant at the target site;
Releasing the implant from the delivery system;
Including methods.
44. At least with a dedicated prosthesis,
A prosthesis delivery system;
At least one valve loader;
A novel enhanced transcatheter heart valve delivery system.
45. 45. A system according to aspect 44 or any one of aspects 1 to 44, further comprising a computer interface having a processor.
46. 46. A system according to aspect 45 or any one of aspects 1 to 45, wherein the processor interfaces with an imaging modality and / or a detection modality.
47. Aspect 46 or aspects 1 to 46 where the installation of the transapical and / or transfemoral artery delivery system is verified by a processor, imaging or sensor and a data stream indicative thereof is captured, stored, and / or transmitted wirelessly The system according to any one of the above.

  The embodiments in this section described above are expressed in the claims and / or can be combined with each of the embodiments and features described herein.

  In particular, aspects 1-47 expressed above and all of the features included in this specification are subject to disclosure within the scope of the appended claims that form part of the disclosure of this application, and each of the features in particular. Can be combined.

  The following details describe and exemplify the alternative and / or exemplary embodiments listed above, in which case the following terms and definitions should apply to aspects 1-47 above. That is, the present disclosure provides for patients with severe symptomatic aortic stenosis and patients with significant aortic regurgitation, or who normally require aortic valve replacement and open heart surgery is associated with increased mortality from surgery. It includes an improved bioprosthesis adapted for the treatment of patients who are considered inoperable (eg, ascending aortic calcification, chest deformity) In the following, the unique disclosure given for consideration and an example of a system for delivery as a direct patentable subject matter will be described.

  The system consists of three main components: a valve prosthesis, a delivery system, and a separate valve loader. Each component is packaged separately.

  The valve prosthesis may consist of porcine pericardial tissue attached to a Nitinol stent scaffold that self-expands using polyester sutures. The scaffold has a crown configuration that can be folded to fit inside either a transapical catheter delivery device or a transfemoral artery delivery device. The valve prosthesis is available in three valve sizes (23 mm, 25 mm, and 27 mm) that accept natural annulus diameters in the range of at least about 21-27 mm as shown in Table 2. The valve is packaged in a polypropylene bottle with glutaraldehyde to maintain sterility. The valve is maintained in the dimensional configuration as deployed in the bottle using a polyoxymethylene ring.

  The valve prosthesis may be composed of porcine pericardial tissue for the leaflets (or tips) and skirts. A glutaraldehyde fixation process is used to crosslink and stabilize the collagen structure of porcine pericardial tissue. The leaflets are formed by joining three tissue panels together and attaching them to a metal stent scaffold with polyester sutures. The prosthesis is sterilized using a solution-based sterilization process and then placed in a glutaraldehyde stock solution until ready for implantation. To clarify how the system of the present disclosure is an improvement over any known prior art and how it is technically different from any known prior art In addition, the following sections give details on each of the structural elements of the prosthesis and give a dimensional overview. FIG. 9 shows this apparatus.

  Stent scaffold: The stent scaffold is formed with three different diameters to accept the final intended annular diameter of the valve. The Nitinol scaffold has a diameter that is larger than the final dimension of the valve to ensure a constant outward force acting on the natural annulus to avoid any valve movement. In addition, as the valve size increases, the height of the stent scaffold is also increased. The outward force of the prosthesis, coupled with the inherent locking function provided by the feeler's crimping mechanism, reduces the known risk of valve movement that has been identified by currently sold TAVR products.

  According to the present disclosure, in an embodiment, the nitinol structure is laser cut from a single tube (OD 7 mm and ID 6 mm). Nitinol is etched into the diamond pattern at the “diamond” portion of the scaffold. The stent scaffold consists of three sets of rails that provide attachment to the leaflet side of pericardial tissue. The stent scaffold also consists of a nitinol structure below the rail called the onion region for pericardial skirt tissue attachment. Furthermore, the stent scaffold consists of a Nitinol support structure called a feeler that allows the valve to attach directly to the leaflets of the natural valve for implantation. The stent scaffold may include an eyelet at least at the end of the stent that engages the delivery system to secure the crimped valve to the delivery system.

  Pericardial tissue: Pericardial tissue is obtained from vendors that supply pig tissue for various medical implants. As mentioned above, pericardial tissue is used for artificial valve leaflets, for valve skirts that seal against natural valves, and for feeler covers to protect natural tissue from possible damage Is done. Tissue is attached to the Nitinol stent scaffold using standard surgical polyester suture material. A 6-0 suture is used to sew the pericardial material against the Nitinol diamond and the commissure tabs. A 5-0 suture is used to sew pericardial material against the rails of the Nitinol scaffold.

  Fabric Tab: The commissure post and feeler each have a PET fabric tab (pledget) that is sewn in place using standard surgical polyester 6-0 suture material. The fabric tabs in commissure are in place to provide structural support during valve assembly, and the fabric tabs on the feeler covering the pericardial tissue may be caused by Nitinol metal In place to protect the natural tissue from.

Valve Embedding Concept In the outflow portion of the valve prosthesis, the self-expanding nitinol stent scaffold includes three eyelets that are formed to align with corresponding recesses in the crown of the delivery system. These paired structures ensure a firm attachment of the prosthesis to the delivery system throughout the entire deployment process during implantation. Additional eyelets may be placed in the inflow portion of the valve.

  According to the present disclosure, the prosthesis also includes three positions of “feelers” that spread apart during delivery of the prosthesis. A feeler is placed behind the natural leaflet and in the sinus region of the base to provide accurate positioning at a predetermined depth of the implant relative to the natural leaflet. To facilitate fluoroscopic visualization during the procedure, the feeler includes a radiopaque marker made from tantalum. The feeler is protected by a small patch of fabric and pericardial tissue sutured to the ends. The Nitinol stent strut at the base of the prosthesis, along with the feeler, provides a mechanism for securing the prosthesis to the natural valve leaflets. 24 inflow parts of the valve form a ring that provides a strength and seal in the radial direction to firmly fix the valve in place with respect to the natural annulus and to minimize side leakage after implantation It is composed of a diamond-shaped support.

  The rails provide attachment space for the leaflets and separate the pericardial skirt region and leaflets. The rails are shaped like a shell to mimic the natural shape of a natural aortic valve and are designed to allow commissural deflections that carry most of the load from the tissue to the stent to extend the durability of the prosthesis. The The skirt seals the prosthesis against the natural annulus.

  The present disclosure contemplates using a transfemoral arterial (TF) delivery system so that a prosthetic valve can be inserted by transfemoral delivery using a specially designed catheter system. The approach is to implant the aortic valve prosthesis via transfemoral access using general or local anesthesia. The TF delivery system consists of two catheters: an introducer sheath assembly and a main deployed delivery system.

  According to certain embodiments of the present disclosure, the femoral-iliac blood vessel is punctured and the introducer sheath assembly (preformed sheath and introducer) is inserted into the femoral artery and the tip of the preformed sheath is naturally It is located in the ascending aorta approximately 2 cm to 4 cm above the valve. When placed in place, the dilator is removed, leaving the preformed sheath in place.

  The preformed sheath has a generally straight segment to fit the path from the femoral artery to the descending thoracic aorta and a curved segment to follow the path from the aortic arch to the aortic valve. The total length of the introducer sheath may be 100 cm to 150 cm. The length of the curved segment may be 15 cm to 30 cm. The curvature radius of the curved segment may be 3 cm to 15 cm, for example 5 cm to 8 cm. The bending angle from the straight segment to the sheath tip may be 90 degrees to 270 degrees, for example 150 degrees to 210 degrees.

  The preformed sheath may be made from a flexible polymeric material such as PEBAX or nylon. The wall of the sheath may be reinforced with a metal blade or metal coil. The inner wall of the sheath may be lined with PTFE to reduce frictional forces. The preformed sheath may have a hydrophilic coating.

  A dilator with an atraumatic tip is inserted into the preformed sheath for insertion into the femoral artery and advancement to the aortic valve. The dilator has a guide wire lumen for receiving a guide wire. A dilator may be preformed. The dilator may be linear. In some embodiments, the dilator is straight and when inserted into the preformed sheath, the curved segment of the preformed sheath is inserted into the femoral artery and the iliac, abdominal and descending aorta. It may be preferable to be almost straight to pass through.

  The valve prosthesis is located in the main delivery system. The inflow segment of the valve prosthesis is constrained by the first sheath. The outflow segment of the valve prosthesis is constrained by the second sheath. The central part of the valve prosthesis including the feeler is not restrained. The first and second sheaths are connected to the first and second actuators, respectively, at the handle of the delivery system. Moving the first actuator distally (toward the tip of the delivery system) moves the first sheath distally and releases the inflow segment of the valve prosthesis. Moving the second actuator proximally (away from the tip of the delivery system) moves the second sheath proximally and releases the outflow segment of the valve prosthesis from the delivery system.

  A steerable catheter is attached to the shaft of the delivery system. The steerable catheter has a handle with a mechanism for deflecting the distal segment of the steerable catheter. The mechanism allows the steerable catheter to bend at least 90 degrees from a straight configuration, such as at least 180 degrees from a straight configuration. Bending the steerable catheter results in a corresponding deflection of the delivery system shaft. The steerable catheter is coaxially disposed on the delivery system shaft and is movable axially and rotationally relative to the delivery system shaft. By rotating the steerable catheter and moving the catheter axially, the position and direction of the shaft deflection of the delivery system can be selected.

  The delivery system is inserted into the preformed sheath with a steerable catheter attached to the shaft of the delivery system. As the partially crimped valve prosthesis enters the preformed sheath, the unrestrained central portion of the valve prosthesis is compressed. Compression of the central portion of the valve prosthesis may be facilitated by a funnel shaped inlet into the preformed sheath. Alternatively, a temporary transfer sheath that compresses the central portion of the valve prosthesis for insertion into the preformed sheath may be disposed on the central portion of the valve prosthesis. The compressed valve prosthesis is pushed through the preformed sheath by pushing the delivery system shaft into the preformed sheath.

  The distal tip of the preformed sheath is placed in the ascending aorta distal to the natural aortic valve. As the valve prosthesis exits the distal end of the preformed sheath, the central portion of the valve prosthesis, including the feeler, expands. Using a preformed sheath to compress this portion of the valve prosthesis for delivery to the natural aortic valve requires the need for a separate mechanism to remove the central portion of the valve prosthesis from the sheath for release of the feeler. Eliminated.

  In order to place the feeler within the natural leaflet, it is beneficial to center the valve prosthesis within the aortic root. This can be accomplished by deflecting and rotating the steerable catheter. The point of deflection can be changed by axially moving a steerable catheter along the shaft of the delivery system. Thus, the distal segment of the delivery system can be shaped by a steerable catheter to follow the path of the individual patient's aorta. In some patients, the ascending aorta is as short as 3-5 cm. In some patients, the ascending aorta is as long as 15-20 cm. In some patients, the aortic arch is curved at less than 180 degrees. In some patients, the aortic arch is curved beyond 270 degrees. The degree of deflection of the delivery system can be controlled by the degree of deflection of the steerable catheter. The position of the delivery system deflection region may be controlled by the axial position of the steerable catheter on the delivery system shaft. The deflection direction of the delivery system can be controlled by the rotational position of the steerable catheter on the shaft of the delivery system.

  The advantage of a preformed sheath is that it deflects the distal end of the delivery system in the general direction of the aortic valve without using a steerable catheter. This reduces the bending force that a steerable catheter must exert on the shaft of the delivery system to deflect the tip of the delivery system to its final position. Axial movement of the preformed sheath relative to the delivery system can also be used to adjust the deflection of the shaft of the delivery system. The preformed sheath protects the aortic wall during operation of the delivery system and steerable catheter.

  When the distal end of the delivery system is centered within the aortic root using a steerable catheter, the valve prosthesis is placed in the aortic annulus by aligning the feeler and the leaflets of the natural aortic valve in the rotational direction. By pushing inward, the feeler is positioned within the natural leaflet. The rotational and axial movement of the valve prosthesis is controlled by the axial and rotational movement of the delivery system within the steerable catheter.

  When the feeler is positioned within the natural leaflet, the valve prosthesis is released by continuously removing the inflow and outflow segments of the valve prosthesis from the sheath. Release of the inflow segment of the valve prosthesis secures the valve prosthesis within the aortic annulus and captures the natural leaflet between the stent prosthesis of the valve prosthesis and the feeler. Release of the valve prosthesis outflow segment removes the valve prosthesis from the delivery system.

  Alternatively, the outflow segment of the valve prosthesis may be released before the inflow segment of the valve prosthesis. In some cases, it may be preferable to release the inflow segment of the valve prosthesis simultaneously with the outflow segment of the valve prosthesis.

  In at least one aspect of the present disclosure, the valve prosthesis may be pre-mounted on the delivery system by the manufacturer. The central portion of the valve prosthesis including the leaflets is not restrained. Pericardial leaflets located in the central portion of the valve prosthesis are not compressed, thereby avoiding long-term compression damage to the leaflets during transportation and storage. It may be possible to remove the distal segment containing the valve prosthesis from the shaft of the delivery system. The distal segment removed with the valve prosthesis may be stored separately from the rest of the delivery system. The distal segment of the delivery system with the partially crimped valve prosthesis attached may be stored in liquid to avoid dehydration of the leaflet tissue. Prior to use, the distal segment of the delivery system is connected to the shaft of the delivery system. The connection mechanism used to attach the distal end of the delivery system to the shaft of the delivery system may take the form of male-female screws, magnets, crimping, or gluing.

  In other aspects of the present disclosure, the valve prosthesis may have an eyelet at at least one end of the stent scaffold to engage the valve prosthesis and the delivery system. The eyelet may be located in a recess in the body of the delivery system. A sheath holds the eyelet in the recess. By securing the eyelet within the delivery system, a “melon seed-like” or premature deployment of a self-expanding stent scaffold from the delivery system is prevented. As long as the eyelet is covered by the sheath, the valve prosthesis will not deploy. The advantage of this configuration is that a large segment of the central portion of the valve prosthesis can be unconstrained to allow complete release of the feeler and minimize tissue leaflet compression. Further, the sheath covering the inflow and outflow segments of the valve prosthesis requires only limited movement to release the eyelet and remove the valve prosthesis from the delivery system.

  In other aspects of the present disclosure, the length of the unrestrained central portion of the valve prosthesis is at least 50% of the total length of the valve prosthesis. In other aspects of the present disclosure, the length of the inflow segment of the valve prosthesis constrained by the distal sheath is less than 20% of the length of the valve prosthesis. In other aspects of the present disclosure, the length of the outflow segment of the valve prosthesis constrained by the proximal sheath is less than 20% of the length of the valve prosthesis.

One embodiment of a delivery system according to the present disclosure is depicted in FIG. Reference numerals used in FIG. 7 are as follows.

One embodiment of a handle assembly for a delivery system according to the present disclosure is depicted in FIG. The reference numerals used in FIG. 8 are as follows.

  Final crimping of the prosthesis is aided by two loading tubes that allow the prosthesis to be secured to the outer shaft by distal movement. It is EO sterilized and is for single use only. It should be noted that the TF valve loader utilizes the same operating principles outlined for the TA valve loader.

  The present disclosure further relates to an apparatus for facilitating removal of the distal end of the catheter from an introducer sheath or guide catheter. A delivery catheter for a stent or transcatheter heart valve may have, for example, a split capsule containing the implant. After the implant is released from the catheter, it may be difficult to pull the open end of the split capsule back into the introducer sheath or guide catheter opening in the blood vessel.

  This aspect of the present disclosure provides a tapered insertion device for leading back into the inner diameter of the introducer sheath or guide catheter for removal of the capsule from the body. The device may be static or self-expanding. The device may also include a step for supporting the implant.

  In one embodiment, the apparatus comprises a tapered cylinder that closes the capsule with a tapered tip by being automatically exposed when the capsule is actuated. In this regard, see FIGS. 13a and 13b. More particularly, FIG. 13a shows one embodiment of a tapered device and FIG. 13b shows a tapered device with a capsule.

  In one embodiment (see FIGS. 14a and 14b), the device is self-folding so that the device can expand to an outer diameter larger than the capsule when exposed. There is also a linear portion at the distal end of the self-folding device that keeps the capsule concentric with the device. The device may be a single piece made from a plurality of parts made from a thermoplastic polymer or assembled together. More particularly, FIG. 14a shows one embodiment of a self-folding device and FIG. 14b shows a self-folding device with a capsule.

  In other embodiments (see FIG. 15), the device is incorporated into a capsule and folded after the implant is released from the capsule. The device may be made from a single piece of thermoplastic polymer and may include a slit or living hinge. The device may be folded mechanically by the user. More particularly, FIG. 15 shows one embodiment of a folding capsule.

  In other embodiments (see FIGS. 16a and 16b), the device is self-expanding. The device is made of a thermoplastic polymer with a living hinge that allows the device to compress to a smaller diameter that fits inside the capsule when not in use. When the capsule is opened, the device expands back to its original diameter that is larger than the capsule diameter. The self-expanding device tapers to facilitate entry into the introducer sheath or guide catheter. Figures 16a and 16b show a device with a step for supporting the inner diameter of the implant. More particularly, FIG. 16a shows one embodiment of a self-folding device and FIG. 16b shows a self-folding device with a capsule.

  In another embodiment (see FIG. 17), the self-expanding device comprises a finger under the capsule to keep the capsule concentric with the device. More particularly, FIG. 17 shows one embodiment of a self-folding device with a centering member.

  In other embodiments (see FIGS. 18a and 18b), the self-expanding device comprises a stabilizer element distal to the self-expanding wedge. The stabilizer maintains the concentricity of the capsule with the device. The external shape of the stabilizer may be different. More particularly, FIG. 18a shows one embodiment of a self-expanding device with a stabilizer and FIG. 18b shows a self-expanding device with a stabilizer and a capsule.

  In other embodiments (see FIGS. 19a and 19b), a stabilizer is removably attached to the inside of the capsule. A spring may be used to actuate the stabilizer. The stabilizer pushes up the self-expanding device again to keep the capsule concentric with the device. The external shape of the stabilizer may be different. More particularly, FIG. 19a shows one embodiment of a self-expanding device with a stabilizer and FIG. 19b shows a self-expanding device with a stabilizer and a capsule.

  In other embodiments (see FIG. 20), the stabilizer and spring may act without a self-expanding device. The stabilizer may have a tapered or conical shape to facilitate entry into the introducer sheath or guide catheter. More particularly, FIG. 20 shows one embodiment of a self-actuating device within a capsule.

  Unless otherwise indicated, all numerical values representing molecular weight, raw materials such as reaction conditions, quantities of properties, etc. used in the specification and claims are to be changed in every case by the term “about”. Should be understood. Thus, unless indicated to the contrary, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired characteristics sought to be obtained by embodiments of the present disclosure. It is. At a minimum, and not as an attempt to limit the application of the doctrine of equivalents to the claims, each numeric parameter should at least be in light of the number of significant figures reported and be subject to common rounding techniques. Should be interpreted by applying. Despite the fact that the numerical ranges and parameters that describe the broad scope of this disclosure are approximate, the numerical values set forth in the specific examples are reported as accurately as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective experimental measurements.

  The terms “a”, “an”, “the” as used in the context of the description of embodiments of the present disclosure (particularly in the context of the following claims) And similar designations should be construed to include both the singular and plural unless otherwise indicated herein or otherwise clearly contradicted by context. . The recitation of a range of values herein is intended only to serve as a shorthand notation for each distinct value falling within that range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually listed herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples or exemplary words (e.g., “etc.”) given herein is merely intended to better describe the embodiments of the present disclosure and is within the scope of the claims. Unless otherwise stated, the scope of the present disclosure is not limited. No language in the specification should be construed as indicating any element not recited in the claims as essential to the practice of the embodiments of the present disclosure.

  Groupings of other elements or embodiments of the disclosure described herein are not to be construed as limiting. Each group member may be referred to and recited in the claims individually or in any combination with other members or other elements of the group found herein. It is anticipated that one or more components of a group may be included or deleted from a group for convenience and / or patentability. Where any such inclusion or deletion is made, the specification is considered to include the modified group, and thus satisfies the written description of the Markush group used in the appended claims.

  Specific embodiments of this disclosure are described herein, including the best mode known to the inventors for carrying out the embodiments of the disclosure. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors anticipate that those skilled in the art will use such variations as needed, and that we do not understand how the disclosure is specifically described herein. It is intended to be implemented in another way. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of all possible variations of the above-described elements is encompassed by the present disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

  Particular embodiments disclosed herein may be further limited in the claims that use the word consisting of or consisting essentially of. As used in the claims, whether applied or amended, the conversion word “consists of” excludes any element, step, or material not specified in the claims. To do. The conversion word “consisting essentially of” limits the scope of the claims to the specified materials or steps and materials or steps that do not substantially affect the basic novel features. The embodiments of the present disclosure as set forth in the following claims are hereby incorporated by reference or become effective.

  Furthermore, numerous references have been made to patents and publications throughout this specification. Each of the cited references and publications mentioned above are individually incorporated herein by reference in their entirety.

  In closing, it is to be understood that the embodiments of the present disclosure described herein are illustrative of the principles of the present disclosure. Other modifications that may be used are within the scope of this disclosure. As such, by way of example, and not limitation, other forms of the present disclosure may be utilized in accordance with the teachings herein. Accordingly, the present disclosure is not limited to that precisely as shown and described.

DESCRIPTION OF SYMBOLS 100 Delivery means 11 Catheter tip 12 Catheter shaft 13 Handle 14 Fixing means 15 1st holding means 16 2nd holding means 17 1st operation means 18 2nd operation means 19 Main body 20 of a handle 20 1st force transmission means 21 Second force transmission means 22 Fixed tube 23 Catheter end tip 30 Steering means 31 Steering catheter tube 32 Handle 33 Operating means 34 Display means 35 Control wire 36 Post portion 40 Introducing body 41 Introducing body sheath 42 Introducing body port 43 Base member 44 Seal structure 45 Crimping part

Claims (71)

i) steering means;
ii) a heart valve, optionally delivery means for a balloon expandable or self-expandable heart valve;
With
A catheter system in which the steering means and the delivery means are movable coaxially and independently in the rotational direction.   The catheter system of claim 1, wherein the system is compatible with an introducer for intravascular use, optionally transfemoral use.   The introducer optionally includes an introducer sheath extending proximally or extendable through the vascular channel, proximal to the target site of the heart, and optionally the introducer sheath The catheter system of claim 2 having a crimping portion.   4. A catheter system according to claim 2 or 3, comprising first and second retaining means at the distal end of the catheter system for reversibly securing the heart valve to the delivery means.   The first holding means reversibly secures the distal end of the heart valve with respect to the delivery means, and the second holding means has the proximal end of the heart valve with respect to the delivery means. The catheter system according to claim 4, wherein the catheter system is reversibly fixed.   6. A catheter system according to any one of the preceding claims, wherein the heart valve is not covered by sleeve means.   The diameter of the fixed heart valve varies over its length, preferably the heart valve is compressible over its length to the inner diameter of the introducer sheath. The catheter system according to 1.   8. The catheter system of claim 7, wherein the inner diameter of the introducer sheath is less than 24 French, preferably less than 20 French, more preferably less than 18 French, and even more preferably less than 16 French.   9. Catheter system according to any one of the preceding claims, wherein the introducer sheath has a preformed, preferably curved configuration.   10. The catheter system of claim 9, wherein the introducer sheath is characterized by a flexible polymer, a hydrophilic coating, a PTFE liner, a coil reinforcement and / or a blade reinforcement.   The catheter system according to any one of claims 1 to 10, wherein the heart valve is attached to the delivery means by a securing means, and the heart valve and the delivery means have complementary shapes.   12. A catheter system according to any one of the preceding claims, wherein the heart valve has male connector elements at the distal and proximal ends for engaging the female connector elements of the delivery means.   A catheter system in which the delivery means and the steering means are operated by one or two means, optionally one or two handles.   14. A catheter system according to any one of the preceding claims, wherein the steering means comprises means for deflecting the delivery catheter shaft from a relaxed configuration to a curved configuration.   The catheter system according to any one of claims 1 to 14, wherein the delivery means and the steering means are releasably connectable. A delivery system for a heart valve,
i) steering means;
ii) delivery means for the heart valve;
iii) an introducer sheath;
With
The delivery system in which the steering means, the delivery means, and the introducer sheath are coaxially movable independently in the circumferential direction.   The delivery system of claim 16, wherein the introducer sheath extends or is extendable through a vascular channel, optionally proximally of the heart.   18. A delivery system according to claim 16 or 17, wherein the steering means, the delivery means and the introducer sheath are arranged coaxially with each other at least in part, partly or almost completely.   The delivery system according to claim 16, 17 or 18, wherein the steering means, the delivery means, and the introducer sheath are movable coaxially and independently in a rotational direction.   20. The delivery system according to any one of claims 16 to 19, wherein the delivery means and the steering means can be introduced into the introducer sheath simultaneously or independently.   21. A delivery system according to any one of claims 16 to 20, wherein the introducer sheath has a crimping portion for reducing the diameter of the heart valve attached to the delivery means. An improved system for delivering a self-expanding implant comprised of an introducer sheath and a delivery catheter to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site;
The delivery catheter has first and second retaining means at the distal end of the delivery catheter for reversibly securing the implant to the delivery catheter;
The first retaining means reversibly secures the distal end of the self-expanding implant to the delivery catheter, and the second retaining means attaches the proximal end of the self-expanding implant to the delivery catheter. Reversibly fixed to
The delivery catheter is threaded through the introducer sheath to deliver the self-expanding implant to the implantation site;
The central segment of the self-expanding implant is compressed from a first diameter to a second diameter smaller than the first diameter when the self-expanding implant is passed through the introducer sheath.
Improved system.   23. The system of claim 22, wherein the implant is at least one of a stent, a stent graft, and a heart valve prosthesis.   24. A system according to claim 22 or 23, wherein the implant has male connector elements at the distal and proximal ends for engaging with female connector elements on the delivery catheter.   25. The system of claim 24, wherein the male connector element is an eyelet and the female element is a recess in the delivery catheter.   26. A system according to any one of claims 22 to 25, wherein the introducer sheath has a hemostasis valve at the proximal end.   27. A system according to any one of claims 22 to 26, wherein the retaining means comprises an axially movable sheath that at least partially restricts radial expansion of the implant. A process for delivering a self-expanding implant to an implantation site in a blood vessel, comprising:
Inserting an introducer sheath from outside the body into a blood vessel through a body opening;
-Placing the distal end of the introducer sheath near the implantation site;
Reversibly securing the distal and proximal ends of the self-expanding implant to the distal end of a delivery catheter;
-Inserting the delivery catheter into the introducer sheath with the self-expanding implant secured to the delivery catheter, wherein the central segment of the self-expanding implant is inserted into the introducer sheath Compressing from a first diameter to a second diameter when
-Pushing the delivery catheter through the introducer sheath until the self-expanding implant exits the distal end of the introducer sheath;
-Releasing the distal and proximal ends of the self-expanding implant from the delivery catheter at the implantation site;
A process involving a combination of A system for delivering an implant comprised of an introducer sheath, a delivery catheter, and a biasing member to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site;
The delivery catheter has holding means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member comprises means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
The delivery catheter is threaded through the introducer sheath to deliver the implant to the implantation site;
The biasing member is movable in an axial direction and a rotational direction with respect to the introducer sheath and the delivery catheter inside the introducer sheath.
system.   30. The system of claim 29, wherein the implant is a self-expanding or balloon expandable heart valve prosthesis.   32. The system of claim 30, wherein the implantation site is a natural aortic valve or a natural mitral valve.   32. A system according to any one of claims 29 to 31 wherein the introducer sheath has a preformed curved configuration. A system for manipulating an implant comprised of an introducer sheath, a delivery catheter, and a biasing member toward an implantation site in a patient's blood vessel,
The delivery catheter has holding means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member comprises means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
The delivery catheter is inserted into the introducer sheath and is movable axially and rotationally within the introducer sheath;
The biasing member is inserted into the introducer sheath and is movable axially and rotationally within the introducer sheath and is movable axially and rotationally relative to the delivery catheter; ,
A system with a combination of things. A method of positioning an implant toward a target site in a blood vessel,
Inserting an introducer sheath from outside the body into a blood vessel through a body opening;
-Placing the distal end of the introducer sheath near the implantation site;
Reversibly securing the implant to the distal end of the delivery catheter;
Placing a biasing member on the shaft of the delivery system having means for actively deflecting the shaft of the delivery system from a relaxed configuration to a curved configuration;
-Inserting the delivery catheter with the implant and the biasing member into the introducer sheath;
-Pushing the delivery catheter through the introducer sheath until the implant exits the distal end of the introducer sheath;
Adjusting the position of the biasing member in the introducer sheath in the axial and rotational directions;
-Actuating the biasing member to deflect the shaft of the delivery system into a desired bending configuration;
-Axially adjusting the position of the delivery system to place the implant at the target site;
-Releasing the implant from the delivery system;
Including methods. A method of loading a self-expanding heart valve onto a delivery catheter having an inner shaft, an attachable distal tip, and at least one outer sheath, comprising:
-Compressing the self-expanding heart valve in a radial direction and placing the compressed self-expanding heart valve in a tubular holder, the self-expanding valve expanding in the radial direction; A step that the holding body prevents;
Passing the inner shaft of the delivery system through a central opening of the compressed self-expanding heart valve;
Attaching the distal tip to the inner shaft of the delivery system;
Pushing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
-Removing the tubular retainer from the compressed self-expanding heart valve;
Including methods. i) steering means;
ii) a heart valve, optionally delivery means for a balloon expandable or self-expandable heart valve;
In combination,
A catheter system in which the steering means and the delivery means are movable coaxially and independently in the rotational direction.   37. The catheter system of claim 36, wherein the system is compatible with an introducer for intravascular applications, optionally transfemoral arteries.   38. The catheter system of claim 37, wherein the introducer comprises an introducer sheath that extends or is extendable through a vascular channel, optionally proximal to a target site of the heart.   39. A catheter system according to any one of claims 36 to 38, having first and second retaining means at the distal end of the catheter system for reversibly securing the heart valve to the delivery means.   The first holding means reversibly secures the distal end of the heart valve with respect to the delivery means, and the second holding means has the proximal end of the heart valve with respect to the delivery means. 40. The catheter system according to any one of claims 36 to 39, wherein the catheter system is reversibly fixed.   41. A catheter system according to any one of claims 36 to 40, wherein the heart valve is compressible to the inner diameter of the introducer sheath.   42. The catheter system of claim 41, wherein the introducer sheath has an inner diameter of less than 24 French, preferably less than 20 French, more preferably less than 18 French, and even more preferably less than 16 French.   43. A catheter system according to any one of claims 36 to 42, wherein the introducer sheath has a preformed curved configuration.   44. A catheter system according to any one of claims 36 to 43, wherein the heart valve has a male connector element at the distal end and the proximal end for engagement with a female connector element of the delivery means.   The delivery means and the steering means are operated by one or two means, optionally one or two handles, in operative relation to the preformed introducer sheath. 45. The catheter system according to any one of 36 to 44.   46. A catheter system according to any one of claims 36 to 45, wherein the steering means comprises means for deflecting the delivery catheter shaft from a relaxed configuration to a curved configuration. A delivery system for a heart valve,
i) steering means;
ii) delivery means for the heart valve;
iii) an introducer sheath;
With
The delivery system in which the steering means, the delivery means, and the introducer sheath are coaxially movable independently in the circumferential direction.   48. The delivery system of claim 47, wherein the introducer sheath extends or is extendable through a vascular channel, optionally proximally of the heart. A method for delivering a heart valve to a patient's heart comprising the steps of:
i) In a first step, an introducer comprising an introducer sheath is placed into the patient's vasculature;
ii) In the second step, a catheter system in which a self-expanding heart valve is fixed is introduced into the patient's vasculature through the introducer,
iii) in a third step, positioning the self-expanding heart valve proximal to the target site in the patient's heart, optionally positioning the heart valve approximately in the middle of the target site;
iv) in a fourth step, positioning the self-expanding heart valve at the target site;
v) In a fifth step, partially releasing the self-expanding heart valve from the catheter system;
vi) In the sixth step, the self-expanding heart valve is completely released from the catheter system;
Method.   50. The self-expanding heart valve is compressed from a first diameter to a second diameter smaller than the first diameter when the self-expanding heart valve is passed through the introducer sheath. The method described in 1. A method of loading a self-expanding heart valve onto a delivery means of a catheter system having an inner shaft, an attachable distal tip, and at least one outer sheath, comprising:
-Compressing the self-expanding heart valve in a radial direction and placing the compressed self-expanding heart valve in a tubular holder, the self-expanding valve expanding in the radial direction; A step that the holding body prevents;
Passing the inner shaft of the delivery system through a central opening of the compressed self-expanding heart valve;
Attaching the distal tip to the inner shaft of the delivery system;
Pushing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
-Removing the tubular retainer from the compressed self-expanding heart valve;
Including methods. A system for delivering a self-expanding implant comprising an introducer sheath and a delivery catheter to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site;
The delivery catheter has first and second retaining means at the distal end of the delivery catheter for reversibly securing the implant to the delivery catheter;
The first retaining means reversibly secures the distal end of the self-expanding implant to the delivery catheter, and the second retaining means attaches the proximal end of the self-expanding implant to the delivery catheter. Reversibly fixed to
The delivery catheter is threaded through the introducer sheath to deliver the self-expanding implant to the implantation site;
The central segment of the self-expanding implant is compressed from a first diameter to a second diameter smaller than the first diameter when the self-expanding implant is passed through the introducer sheath. .   53. The system of claim 52, wherein the implant is a stent, a stent graft, or a heart valve prosthesis.   54. A system according to claim 52 or 53, wherein the implant has male connector elements at the distal and proximal ends for engaging with female connector elements on the delivery catheter.   55. The system of claim 54, wherein the male connector element is an eyelet and the female element is a recess in the delivery catheter.   56. A system according to any one of claims 52 to 55, wherein the introducer sheath has a hemostasis valve at the proximal end.   57. A system according to any one of claims 52 to 56, wherein the retaining means comprises an axially movable sheath that at least partially restricts radial expansion of the implant. A method of delivering a self-expanding implant to an implantation site in a blood vessel, comprising:
Inserting an introducer sheath from outside the body into a blood vessel through a body opening;
-Placing the distal end of the introducer sheath near the implantation site;
Reversibly securing the distal and proximal ends of the self-expanding implant to the distal end of a delivery catheter;
-Inserting the delivery catheter into the introducer sheath with the self-expanding implant secured to the delivery catheter, wherein the central segment of the self-expanding implant is inserted into the introducer sheath Sometimes compressed from a first diameter to a second diameter; and
-Pushing the delivery catheter through the introducer sheath until the self-expanding implant exits the distal end of the introducer sheath;
-Releasing the distal and proximal ends of the self-expanding implant from the delivery catheter at the implantation site;
Including methods. A system for delivering an implant comprised of an introducer sheath, a delivery catheter, and a biasing member to an implantation site in a patient's blood vessel, comprising:
The introducer sheath extends from outside the patient's body to near the implantation site;
The delivery catheter has holding means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member comprises means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
The delivery catheter is threaded through the introducer sheath to deliver the implant to the implantation site;
The biasing member is movable in an axial direction and a rotational direction with respect to the introducer sheath and the delivery catheter inside the introducer sheath.
system.   60. The system of claim 59, wherein the implant is a self-expanding or balloon expandable heart valve prosthesis.   61. A system according to claim 59 or 60, wherein the implantation site is a natural aortic valve or a natural mitral valve.   62. A system according to any one of claims 59 to 61, wherein the introducer sheath has a preformed curved configuration. A system for manipulating an implant composed of an introducer sheath, a delivery catheter, and a biasing member toward an implantation site in a patient's blood vessel,
The delivery catheter has holding means for reversibly holding the implant at the distal end of the delivery catheter;
The biasing member comprises means for deflecting the shaft of the delivery catheter from a relaxed configuration to a curved configuration;
The delivery catheter is inserted into the introducer sheath and is movable axially and rotationally within the introducer sheath;
The biasing member is inserted into the introducer sheath, is movable in the axial direction and rotational direction within the introducer sheath, and is movable in the axial direction and rotational direction relative to the delivery catheter; is there,
system. A method of positioning an implant toward a target site in a blood vessel comprising inserting an introducer sheath from outside the body through a body opening into the blood vessel,
Installation is
-Placing the distal end of the introducer sheath near the implantation site;
-Reversibly securing the implant to the distal end of the delivery catheter;
Placing a biasing member on the shaft of the delivery system having means for actively deflecting the shaft of the delivery system from a relaxed configuration to a curved configuration;
-Inserting said delivery catheter together with said implant and said biasing member into said introducer sheath;
-Pushing the delivery catheter through the introducer sheath until the implant exits the distal end of the introducer sheath;
The method achieved by A method of loading a self-expanding heart valve onto a delivery catheter having an inner shaft, an attachable distal tip, and at least one outer sheath, comprising:
-Compressing the self-expanding heart valve in a radial direction and placing the compressed self-expanding heart valve in a tubular holder, the self-expanding valve expanding in the radial direction; A step that the holding body prevents;
Passing the inner shaft of the delivery system through a central opening of the compressed self-expanding heart valve;
Attaching the distal tip to the inner shaft of the delivery system;
Pushing the outer sheath toward the compressed heart valve to prevent radial expansion of at least a portion of the heart valve;
-Removing the tubular retainer from the compressed self-expanding heart valve;
Adjusting the position of the biasing member in the introducer sheath in the axial and rotational directions;
-Actuating the biasing member to deflect the shaft of the delivery system into a desired bending configuration;
-Axially adjusting the position of the delivery system to place the implant at the target site;
-Releasing the implant from the delivery system;
Including methods. -At least a dedicated prosthesis;
-A prosthesis delivery system;
-At least one valve loader;
A novel enhanced transcatheter heart valve delivery system.   The system of claim 66, further comprising a computer interface having a processor.   68. A system according to claim 66 or 67, wherein the processor interfaces with an imaging modality and / or a detection modality.   69. A transapical and / or transfemoral artery delivery system installation is verified by the processor, imaging or sensor, and a data stream indicative thereof is captured, stored, and / or transmitted wirelessly. The system according to any one of the above. A method for delivering a heart valve to a patient's heart comprising the steps of:
i) In a first step, an introducer comprising an introducer sheath is placed into the patient's vasculature;
ii) In the second step, a catheter system comprising a self-expanding or balloon expandable heart valve fixed is introduced through the introducer into the patient's vasculature;
iii) in a third step, positioning the heart valve proximal to the target site in the patient's heart, optionally positioning the heart valve approximately in the middle of the target site;
iv) in a fourth step, positioning the heart valve at the target site;
v) in a fifth step, partially releasing the heart valve from the catheter system;
vi) In the sixth step, the heart valve is completely released from the catheter system;
Method.   The self-expanding heart valve compresses from a first diameter to a second diameter smaller than the first diameter when the self-expanding heart valve is passed through the introducer sheath, preferably a crimping portion. 71. The method of claim 70, wherein: